Download Relationship of epicardial adipose tissue thickness with cardiac output.

RELATIONSHIP OF EPICARDIAL ADIPOSE TISSUE
THICKNESS WITH CARDIAC OUTPUT
JANUARY 2011
SREEDEVI.M
1
RELATIONSHIP OF EPICARDIAL ADIPOSE TISSUE
THICKNESS WITH CARDIAC OUTPUT
JANUARY 2011
SREEDEVI.M
2
RELATIONSHIP OF EPICARDIAL ADIPOSE TISSUE THICKNESS WITH
CARDIAC OUTPUT
A dissertation protocol submitted in partial fulfillment of first year MPT
(MASTER OF PHYSIOTHERAPY) in Cardiopulmonary sciences
MANIPAL UNIVERSITY
January 2011
BY
SREEDEVI.M
Under the guidance of
Mrs. Bhamini. K. Rao, MPT
Associate Professor
Dept. of Physiotherapy
MCOAHS,Manipal University,
Manipal.
Mr. Kalyan Chakravarthy, MPT
Associate Professor
Dept. of Physiotherapy
MCOAHS,Manipal University,
Manipal.
3
MANIPAL COLLEGE OF ALLIED HEALTH SCIENCES
MANIPAL UNIVERSITY
Manipal
CERTIFICATE
This is to certify that this dissertation protocol on
RELATIONSHIP OF EPICARDIAL ADIPOSE TISSUE
THICKNESS WITH CARDIAC OUTPUT has been done by
SREEDEVI.M under our supervision. We are satisfied with the
work presented by the candidate towards the partial fulfillment
of first year Master of Physiotherapy in Cardiopulmonary
sciences.
Mrs. Bhamini.K.Rao, MPT
Guide
Associate Professor
Dept .of Physiotherapy
MCOAHS
Manipal University,
Manipal.
Mr. Kalyan Chakravarthy,MPT
Co Guide
Associate Professor
Dept. of Physiotherapy
MCOAHS
Manipal University,
Manipal.
Date:
4
MANIPAL COLLEGE OF ALLIED HEALTH SCIENCES
MANIPAL UNIVERSITY
Manipal
CERTIFICATE
This is to certify that this dissertation protocol on
RELATIONSHIP OF EPICARDIAL ADIPOSE TISSUE
THICKNESS WITH CARDIAC OUTPUT has been done by
SREEDEVI.M under our supervision. We are satisfied with the
work presented by the candidate towards the partial fulfillment
of first year Master of Physiotherapy in Cardiopulmonary
sciences.
Dr. G.Arun Maiya PhD
Dr.B.Rajashekhar
Professor and HOD
Professor
Dept of Physiotherapy
Dept of Speech and Hearing
Associate Dean
MCOAHS,Manipal University,
Manipal
Dean
MCOAHS,Manipal University,
Manipal
Date:
5
CONTENTS
1.INTRODUCTION……………………………………..7
2.LITERATURE REVIEW……………………………..13
3.METHODOLOGY……………………………………..29
4.REFERENCE…………………………………………..28
5.APPENDIX………………………………………………31
6
INTRODUCTION
7
Overweight and obesity is defined as abnormal or excessive fat accumulation that
may impair health. WHO (2010) defines “overweight” as a BMI equal to or more than
25, and “obesity” as a BMI equal to or more than 30. Obesity has reached epidemic
proportions globally, with more than one billion adults being overweight and at least 300
million of them clinically obese, and it is a major contribution to the global burden of
chronic disease and disability.1 In India, urbanization and modernization has been
associated with obesity. Obesity is more prevalent in urban population and among
females more than the males in both rural and urban population.2
Cardiovascular diseases are more prevalent in obese with excessive amount of
intra-abdominal visceral adipose tissue (VAT).3,5 VAT is present in the abdominal wall
and thoracic cavity. In thoracic cavity, it is primarily present in the epicardial and
pericardial fat sub-compartments.4 Epicardial adipose tissue (EAT) covers 80% of the
hearts surface and constitutes 20% of the total heart weight. There is 3 to 4 fold more
fat associated with right than the left ventricle.EAT is a recognized indicator of cardiac
risk, significantly correlating with severity of Coronary Heart Diseases.5
Typically, normal fat distribution in the heart are restricted to the grooves between
the atrium and ventricles, between ventricles and along the coronary arteries. As the
mass of EAT increases, the ventricular surfaces become covered with adipose tissue
.EAT is a very active endocrine organ and may have an effect on local coronary artery
health.6
Increase in EAT seems to be associated with increased ventricular mass and
thereby leading to abnormal cardiac morphology . Hypertrophy is a compensatory
remodelling of the left ventricle in response to a pressure or a volume overload and the
combined effect of metabolic and neuro-hormonal factors. The presence of excessive
epicardial fat adds to the weight of the ventricles and increases the effort involved in
pumping blood around the body. Adipose and muscular component of the heart share
the same coronary blood supply7.
8
The age, sex and degree of obesity are associated with the varied distribution of
VAT4. Excess VAT has a detrimental effect on sub-maximal aerobic capacity. Fick’s
principle states that VO2 peak will occur when the maximal arterio-venous oxygen
difference and the cardiac output (CO) reach their maximum during an exercise test.
Thus VO2 peak is directly related to the maximal arterio-venous oxygen difference and
CO. CO has been recognized as the most important measurement in the assessment of
cardiac pump function and overall hemodynamic function.8
In a study done by Stelfox H T,Ahmed R A et al,body mass index positively
correlated with CO and SV. Each 1 kg/m increase in BMI was associated with a
0.08L/m increase in CO and 1.35ml increase in stroke volume(SV).But there is no
literature on the effect of EAT on CO and ejection fraction (EF) in response to submaximal cardio-respiratory exercise testing.9
Various methods to quantify the visceral adipose tissue directly by MRI, radiation
exposing computed tomography and echocardiography, as well as indirectly by
anthropometric measures ( e.g: waist-circumference, body mass index) . MRI is the gold
standard technique to accurately measure visceral adiposity although there is some
concern about the accuracy of actual visceral adiposity content based on single slice
sampling lie whole body magnetic resonance imaging scan is the true gold standard ).
Waist circumference as measure of visceral obesity may be less reliable in older
persons waist circumference may be a better measure of subcutaneous rather than
visceral adiposity10. Body mass index, an anthropometric measure of visceral adiposity
is suggested to be a poorer indication of cardiovascular risk than waist – circumference
across ethnicities, suggesting that body mean index may not be a very good measure of
visceral obesity11.
Even though the gold standard method to measure epicardial adipose tissue
thickness is MRI, echocardiography has shown to be a reliable method to measure the
adipose thickness. Gianluca Iacobellis et.al validated trans-thoracic echocardiography
as an accurate , easy and reliable imaging method for VAT prediction and it showed an
excellent correlation between VAT obtained from echocardiography and MRI
VAT(r=0.442,P=0.02).12
9
Sub-maximal exercise test estimates cardio-respiratory fitness level and is less
risky. It assumes a steady – state heart rate (HR) at each exercise intensity and a linear
relationship exists among HR, O2 uptake and work intensity.13 Immediate response of
the cardiovascular system to exercise:
1. Heart rate:- After the initial anticipatory response, heart rate increases in direct
proportional to exercise intensity until a maximum heart rate is reached.
2. Stroke volume:- Stroke volume (SV) increases proportionally with exercise intensity.
In untrained individuals SV at rest averages 50-70 ml/beat,increasing upto 110130ml/beat during intense physical activity. In elite athletes resting SV averages 90110ml/beat increasing to as much as 150-220ml/beat. SV may increase only upto 4060% of maximal capacity after which it plateaus. Beyond this relative exercise intensity,
SV remains unchanged right upto until the point of exhaustion.
3. Cardiac output :- Cardiac output (CO) increases proportionally with exercise intensity
which is predictable from response of heart rate and SV to activity. At rest, CO is about
5L/min. During intense exercise this can increase to 20-40L/min.14,15,16,17,18.
There are studies which have been done on the relationship of epicardial adipose
tissue thickness on the body mass index and heart rate recovery, but no studies have
been done on the relationship of epicardial adipose tissue thickness on the stroke
volume, cardiac output, ejection fraction.
The exact mechanism of how high amount of epicardial adipose tissue thickness
affects the heart function and the cardio-respiratory fitness is not known.
10
NEED OF THE STUDY:
Relationship between the varying amount of thickness of epicardial adipose tissue
with cardiac output in response to sub-maximal exercise is not known.
CLINICAL SIGNIFICANCE:
This study may help to determine the influence of epicardial adipose tissue
thickness on the heart function with sub-maximal exercise and indirectly one of the
probable cause for reduced exercise capacity.
11
OBJECTIVES
To correlate epicardial adipose tissue thickness with:
a) Resting and sub-maximal cardiac output.
b) Resting and sub-maximal left and right ventricular ejection
fraction.
c) Resting heart rate, sub-maximal heart rate and heart rate
recovery.
12
LITERATURE
REVIEW
13
The literature search was done in pubmed/medline,pubmed central,science
direct,Wikipedia,proquest medical library.
The following key words were used:epicardial adipose tissue,cardiac output,submaximal exercise,body mass index,overweight and obesity.
Literature review will br explained under the following :
1.Epicardial fat:properties,function and relationship to obesity
2. Echocardiography and epicardial adipose tissue thickness measurement
3.Threshold values of high risk Echocardiographic epicardial fat thickness
4. Epicardial adipose tissue, relationship with cardio-respiratory fitness
1.Epicardial fat: properties, function and relationship to obesity.
The purpose of the review was to examine the anatomic and biochemical data on
epicardial fat, to examine the relationship of epicardial fat to obesity and to explore the
potential role of epicardial fat in the relationship of obesity to coronary atherothrombotic
disease. Physiologic functions of epicardial fat include: buffering coronary arteries
against the torsion induced by the arterial pulse wave and cardiac contraction,
facilitating coronary artery remodeling, regulating fatty acid homeostasis in the coronary
microcirculation and providing fatty acids to cardiac muscles as a local energy source in
times of high demand.
The study indicates that epicardial fat mass increases until 20-40 years but
thereafter the amount of epicardial fat is not dependent of age. A number of properties
differentiate epicardial fat from other fat depots specifically its smaller adipocytes size,
different fatty acid composition, high protein content; high rates of fatty acid
incorporation, fatty acid synthesis, insulin induced lipogenesis or fatty acid breakdown,
low rates of glucose utilization. There is a significant direct relationship between the
14
amount of epicardial fat and general body adiposity. Clinical imaging studies have
demonstrated a strong direct correlation between epicardial fat and abdominal visceral
adiposity.
Several lines of evidence support a role for epicardial fat in the pathogenesis of
coronary artery disease namely the close anatomic relationship between epicardial fat
and coronary arteries, the positive correlation between the amount of epicardial fat and
the presence of coronary atherosclerosis and the ability of adipose tissue to secrete
hormones and cytokines that modulate coronary artery atherothrombosis.
Thus, epicardial fat maybe an important factor responsible for cardiovascular
disease in obesity.19
2 Echocardiographic epicardial fat:
Previous study has shown that two – dimensional trans-thoracic Doppler
Echocardiography can be used to measure the cardiac response to exercise. For direct
assessment of the epicardial adipose tissue as a marker for visceral adiposity, subjects
undergo echocardiography as proposed by Iacobellis et al. with the subjects in the
lateral decubitus position, two dimensionally guided M-mode echocardiography was
performed using an Envisor C, Philips, with a 2.5-MHz transducer. The largest
dimension of this space was in the end – diastolic period and was measured from
trailing edge to the leading edge on the free wall of the right ventricle (RV), this
measurement was considered as the maximum EF thickness in two standard
echocardiographic views. To decrease variability, three cardiac cycles were read and
measured in the end-diastolic period on the parasternal long-axis of the free wall of the
right ventricle. The area above the RV was preferred to measure EF thickness, because
this area is considered to have the thickest EAT layer.
Parasternal long and short- axis views allow the most accurate measurement of EAT
thickness with optimal cursor beam orientation in each view. Thickest point of EAT was
measured.6
15
To assess the reproducibility of the echocardiographic measurement of EF thickness,
subjects were randomly selected for off-line analysis by two observers who were
unaware of metabolic and clinical data. Interclass correlation co-efficient was 0.91,
interclass correlation coefficient was 0.93, suggesting an excellent reproducibility of this
fat thickness.
Subjects with high EF exhibited a blunted heart rate response to exercise stress as
compared with low EF subjects. It has been reported that a delay in the decrease of HR
during the first minute after maximal exercise testing is strongly predictive of mortality at
6 years 20.
3.Threshold values of high risk Echocardiographic epicardial fat thickness:
In another recent study, threshold values of echocardiographic epicardial fat
thickness associated with metabolic and anthropometric risk factors was conducted.
Epicardial fat thickness of 9.5 and 7.5mm maximize the sensitivity and specificity to
predict metabolic syndrome in men and women respectively. In separate analysis,
epicardial fat thickness of 9.5 and 7.5 mm were cutoff points associated with high
abdominal fat in men considered separately, epicardial fat thickness of 9.5mm was
associated with insulin resistance.
Epicardial fat thickness values of 9.5 and 7.5mm should be considered the
threshold values for high risk echocardiographic epicardial fat thickness in white men
and women . echocardiographic epicardial fat measurement maybe of help for
cardiometabolic risk stratification and therapeutic interventions targeting the fat.
It was concluded that EAT values of 9.5mm in men and 7.5mm in women are
associated with metabolic syndrome and risk of cardiovascular diseases.
BMI classification
EAT thickness (mm)
Normal weight
4(1.1 – 5)
Overweight
6.7(5.5 – 10)
16
Class 1
6.6(5 – 10.5)
Class 2
7(5.7 – 11.8)
Class 3
8.9(6 – 22)
Unlike CT, echocardiography does not use ionizing radiation. Therefore ,
echocardiography may be more practical for longitudinal population studies of intrathoracic VAT13 .
4.Relationship with Epicardial adipose tissue and cardio-respiratory fitness:
It has been well established that epicardial fat (EF) tissue significantly correlates
with the severity of coronary heart diseases, but only a few studies have been
conducted to determine the association between EF thickness and autonomic
dysfunction and cardiovascular fitness.
In one of this recent studies, the purpose was to study the influence of the
epicardial fat tissue on the aspects of heart rate recovery (HRR) and cardio-respiratory
fitness (VO2 peak) in middle aged men was conducted. A cross-sectional analysis of
epicardial fat (EF) tissue thickness was performed on 101 overweight and obese adult
men. They were categorized into low-EF, moderate-EF, and high EF groups on the
basis of ventricular EF thickness, as measured by trans-thoracic echocardiography.VO2
peak was assessed with a graded maximal cycle ergometric test, including
measurement of HRR at 2 min after test cessation to estimate parasympathetic activity,
with assessment of several metabolic parameters.
The findings were: first, higher EF thickness as assessed by echocardiography
is independently associated with lower HRR at 1 and 2 min, a measure of autonomic
dysfunction. Second , fat tissue is associated with cardio-respiratory fitness (anaerobic
threshold and VO2peak). Third, in stepwise multiple regression analysis, EF thickness
alone explained 12.2% of VO2 peak variance, independent of age, BMI, fat free mass,
total fat mass, legs ,trunk fat mass, this indicates the possible involvement of EF tissue
17
in cardio-respiratory fitness regardless of fat levels in other areas of the body, atleast
among men. High EF group exhibited a blunted HR response to exercise stress, as
compared with the low-EF group.
Subjects with higher EF thickness were more likely to have impaired recovery
and to reveal lower cardio-respiratory fitness than low-EF group subjects. There was a
significant partial correlation, adjusted by age and body weight, between EF thickness
and VO2 peak. The conclusion of the study was that higher epicardial fat thickness in
men is associated with lower HRR at 1 and 2 min, a representation of autonomic
dysfunction and poor cardio-respiratory fitness. The data suggested that moderately
obese men with thicker EAT tissue demonstrate reduced cardio-respiratory fitness and
a differing parasympathetic response to exercise testing, as compared with men lower
EAT levels
The clinical significance of structural change in EF thickness is gradually emerging.it
has been suggested that regular physical activity and weight control are important with
respect to cardiovascular health.Recent studies have demonstrated thet Ef thickness
can be modified by participation in regular, organized physical activity or by diet-induced
weight loss in an obese population. The limitation of the study ia that it included only
male and predominantly overweight and obese subjects. 8.
18
METHODOLOGY
19
Study design :
Cross sectional study.
Sampling method :
Convenience sampling.
Subjects :
Verbal advertisements.
Setting :
Cardiology Department, Kasturba Hospital , Manipal.
Investigators:
Student pursuing postgraduation in cardiopulmonary physical therapy,
Cardiologist.
Sample size:
Pilot study will be done including 5 males and 5 female subjects.
Based on the results of the pilot study, sample size will be calculated.
20
Inclusion criteria:
Subjects with
1. Age between 18 to 45 years
2. BMI - >24.9kg/m2
3. Both male and female sedentary individuals (who
exercise less than 3 times/week)
Exclusion criteria:
1. Subjects with any known respiratory and musculoskeletal
conditions.
2. Subjects on regular medications
21
PROCEDURE
Approval from the Ethical Committee will be sought, following which a verbal
advertisement will be given among all staff and students of the constituent colleges of
Manipal University. Volunteers will be undergoing a complete cardiac evaluation to rule
out any major cardiac conditions. A written informed consent will be obtained from all
the eligible subjects .Procedure will be explained to the subjects and the baseline
characteristics will be measured are: Age(years), height(cm), weight(kg),
BMI(kg/m2),EAT thickness(mm), Heart rate(bpm), Stroke volume(ml/beat), Cardiac
output(L/min), Ejection fraction(%).
Epicardial adipose tissue (EAT) thickness and Resting Cardiac Output (CO) and
Ejection Fraction (EF) will be measured in the left lateral decubitus position. A single
experienced cardiologist will be measuring EAT,CO, EF using Trans-thoracic view and
B-mode echocardiography. Warm up of 5 minutes given to the subjects prior to the
exercise. Subjects allowed to walk on the treadmill for 2 mins to familiarize the
instrument. Then walk on the treadmill according to stages of Balke protocol.
Instruments :
1.Treadmill (adjustable inclination)
2.Echocardiogram
3.Stop watch.
22
Balke protocol
Parameters
Treadmill speed
Start grade
After 1 min
After 2 minsand 1 min
thereafter
Men
3.3mph
Women
3.0mph
0%
0%
Grade set at 2%
Grade increased by 1%
After 3 mins and every 3
mins thereafter
Grade increased by 2.5%
Stop wacth started at the start of the test and stopped when the subject
continue , ideally being 9 to 15 mins.
is unable to
Termination criteria:
1. Onset of angina or angina-like symptoms
2. Significant decrease in SBP of 20mmHg or more
3. Light-headedness, confusion, ataxia, pallor, cyanosis, nausea, or signs of severe
peripheral circulatory insufficiency
4. Excessive increase in BP,systolic >260mmHg,diastolic >115mmHg
5. Subject requests to stop test for whatever reason
6. Equipment failure
Immediately after exercise subject will be made to lie on the left lateral position
as before. CO and EF measured post exercise also. Once the complete outcome
parameters are measured,subjects will be given stretching exercises to prevent
deleterious effects of passive cool down.
23
Flow chart describing the procedure
Approval will be obtained from the Ethical Committee
Sample will be collected through verbal advertisements
Eligible subjects will be recruited into the study(according to
inclusion/exclusion criteria)
A written informed consent will be obtained from all the subjects
Procedure explanation to the subjects
Familiarization of the treadmill to the subjects(2 mins)
Sub-maximal exercise on the treadmill(Balke protocol)
Outcomes measure
24
OUTCOME MEASURE
Primary outcome measure:
1. Resting and Sub-maximal Cardiac Output
Secondary outcome measure:
2. Resting and Sub-maximal Ejection Fraction
3. Heart Rate Recovery
25
DATA ANALYSIS
26
1.Data analysis with SPSS version 17
2.Pearson’s correlation co-efficient :
a) To correlate between the EAT and resting CO
b) To correlate between the EAT and sub-maximal CO
3.ANOVA: to compare the heart rate at different duration post-exercise.
a)Resting HR
b)HRR at min 0
c)HRR at min 1
d)HRR at min 3
e)HRR at min 5
4.Level of significance p ≤ 0.05
27
REFERENCES
28
1. WHO ,Global strategy on Diet,Phys.Act and Health ,Obesity and
Overweight,2010.www.int/dietphysicalactivity/publications/facts/obesity/en/int/diet
physicalactivity/publications/facts/obesity/en/ index.html;access
on15.10.10
2. WHO, 2007; en.wikipedia.org/wiki/epidemiology of obesity;
accessed on 15.10.10
3. Despres JP.Is visceral obesity the cause of the met.syndrome? Ann Med
2006;38:52-63.
4. Willens H J, Gomez-Marin O. Comparison of epicardial and pericardial fat
thickness assessed by echocardiography in African American and Non-Hispanic
White Men, Piolt study.
5. Church TS, Cheng YJ, Earnest CP et al. Exercise capacity and body composition
as predictors of mortality among men with diabetes. Diabetes care, 2004;27:838.
6. Navneet Singh, Harleen, Gianluca Iacobellis. Echocardiographic Assessment of
Epicardial adipose tissue –A marker of visceral adiposity, review article , MJM
2007 10(1):26-30.
7. Gianluca Iacobellis, Arya M, Sharma. Cardiac adiposity and Cardiovascular Risk,
potential role of Epicardial Adipose Tissue; Current Cardiology
Reviews,2007,3,11-14.
8. Maeng-Kyu, Kiyoji Tanaka, Mi-Ji Kim et al, 2010, epicardial fat tissue:
Relationship with Cardiorespiratory fitness in men. J of American College of
Sports Medicine.
9. Stelfox H T, Ahmed R A et al. Hemodynamic monitoring in obese patients, the
impact of BMI on CO and SV. Crit care med.2006 Apr;34(4):1243-6.
10. Imaging .J.P.Coffey,J C Hill.CO and Index in obese and non-obese patients
using Gated single Photon Emission CT Sestemibi Perfusion.J H K Radiol
2005;8:226-232.
11. Heyward V H. Advanced Fitness Assessment and Exercise Prescription. 2006.
29
12. Jin – Sun Park, Sung-Gyun Ahn, Jung-Won Hwang et al. Impact of Body Mass
Index on the relationship of epicardial adipose tissue to metabolic syndrome and
coronary artery disease in an Asian population Cardiovascular Diabetology
2010,9:29
13. Gianluca Iacobellis, Willens H J et al. Threshold values of high risk
Echocardiographic Epicardial fat thickness. Obesity (2008)16 4,887-892.
14. Rowell LB, Human Cardiovascular Control,1993.
15. Wilmore JH, Costill DL; Physiology of Sport and Exercise:3rd
edition,Champaigh,IL: Human Kinetics.2005.
16. Crawford MH,Petru MA et al/Effect of isotonic exercise training on the left
ventricular volume during upright exercise.Circulation. 1985;1237-43.
17. Higginbotham HB,Morris KG et al.Regulation of stroke volume during
submaximal and maximal upright exercise in normal man. Circ.
Res.1986;58(2):281-91.
18. McArdle WD, Katch FL et al;Essentials of Exercise Physiology,2 nd edition
Philadelphia;2000.
19. Rabkin SW;Epicardial fat: properties, function and relationship to obesity,2006.
20. Gianluca iacobellis, Willens H J etal. Echocardiographic epicardial fat :A review
of Research and Clinical Applications. J Am Soc Echocardiogr, 2009; 22:1311-9.
30
APPENDICES
31
DATA COLLECTION FORM
Name :
Age :
Gender :
Height :
Weight :
Contact information :
BMI:
Parameters
Resting
Post - exercise
EAT
Heart rate
Min 0:
Min 1:
Min 3:
Min 5:
Stroke volume
Cardiac output
Ejection fraction
32
SUBJECT INFORMATION SHEET
Protocol title: Relationship of epicardial adipose tissue thickness with cardiac output.
Principal Investigator: Sreedevi.M
Designation: Partial fulfillment of first year MPT student.
Hospital: Kasturba Hospital, Manipal
Contact number:
Please read this form carefully. If you don’t understand the language or any information in this
document, please discuss with investigator. If you decide to volunteer to take part in this study
you must sign the end of this form.
Purpose of research:
I have been informed that this study is intended to study the relationship between the
epicardial adipose tissue thickness (fat around the heart) on sub-maximal cardiac output
(heart function after the exercise) in overweight and obese adults.
Who can take part :
Subjects with age between 18 to 45 years, body mass index more than 24.9kg/m2, those who
exercise less than three times per week. Subjects with no musculoskeletal and respiratory
conditions and those who are not on regular medication.
Procedure:
I have understood the procedure clearly and I am ready to undergo echocardiography,
exercise for 20 minutes, that is warmup for 5 minutes , exercise on treadmill till I get
exhausted or for 10 minutes according to the method used, following a practice/trial for
2 minutes on treadmill so that I get to know the right technique , then again I will be
made to undergo echocardiography measurements in the same position as before, then
cool down exercises for 5 minutes after measurements.
33
Your role/responsibility in the study: Role of the subject during the study.
1.Provide accurate information whenever asked.
2.Follow the investigators instruction.
3. If you want to discontinue from the study, investigator to be informed (If you want to
discontinue from the study inform the investigator.)
Risk and discomfort:
I was made sure that complete privacy would be given, as there are chances of getting
exhausted or tired even before completing the procedure, I was told that I can stop the
exercise at any point when I feel discomfort or exhausted.
Benefits:
I understand that if I become a part of the study, I will come to know how good is my
heart function, and if it is poor I would like to continue the exercises regularly under
supervision and improve my fitness level.
Confidentiality:
Information from the study including your name, address, medical records, results of tests, study
results will be reviewed only by authorized personnel from the sponsor or their representative,
Ethics Committee or regulatory bodies. Information and results from this study may be presented
at meetings or published in journals without including your name and personal identifications.
New information about the study:
Any new information available during the course of the study will be informed to you if it has
relevance to your decision regarding continuing in the study.
The data collected will be used for publication in the journal. I am aware that no names,
photographs and video recordings of mine will not be published without seeking the
permission from me.
Cost of participating in the study:
All tests and procedures required by the study are provided at no cost to you.
34
Voluntary participation:
Entering a research study is voluntary. If you volunteer for a research study, you have the right to
stop at any time and you need not give any reason for the same. Sponsorer or the investigator
may stop the research or your participation in it at any time for some or other reason without your
permission.
35
INFORMED CONSENT FORM
Project title: Relationship between epicardial adipose tissue thickness with cardiac output.
Name of the Research Subject:
Age of the Research Subject:
I have read the Subject Information Sheet and its contents were explained. I had the opportunity
to ask questions and received satisfactory answers.
I understand that my participation in the study is voluntary and that I have the right to withdraw at
any time without giving any reason, without my medical care or legal rights being affected.
I agree to take part in the above study. I confirm that I have received a copy of the subject
information sheet along with this signed and dated informed consent form.
__________________________
_________
Signature of the research subject
Date
__________________________
Name of the research subject
_________________________
Signature & the name of the witness
_________
Date
_____________________________________
_________
Signature of the person explaining the consent
Date
__________________________________
_________
Name of the person explaining the consent
Date
36
ಅಧ್ಯಯನದಲ್ಲಿ ಭಾಗವಹಿಸುವವರ ವಿವರಗಳ ಬಗೆಗಿನ ಹಾಳೆ
ಅಧ್ಯಯನದ ಶೀರ್ಷಿಕೆ: ರಿಲೆೀಶನ್ ಆಫ್ ಎಪಿಕಾರ್ಡಿಯಲ್ ಅರ್ಡಪೀಸ್ ಟಿಸ್ಸು ತಿಕ್ ನೆಸ್ ವಿದ್ದ್ ಕಾರ್ಡಿಯಕ್ ಔಟ್
ಪುಟ್.
ಪರಧ್ಾಯನ ಅಧ್ಾಯಯನಕಾರರಸ: ಶರೀದೆೀವಿ ಎಮ್.
ಹಸದೆ್ : ಅಧ್ಿವರ್ಷ ಕಲಿತ ಎಮ್ ಪಿ ಟಿ ಮೊದಲನೆೀ ವಷಿದ ವಿದಾಯರ್ಥಿನಿ.
ಆಸ್ಪತ್ೆರ : ಕಸ್ತೂರ್ಾಿ ಆಸ್ಪತ್ೆರ ಮಣಿಪಾಲ.
ಸ್ಂಪರ್ಕಿಸ್ಬಹಸದಾದ ಸ್ಂಖ್ೆಯ:
ಈ ಹಾಳೆಯನಸು ಸ್ರಿಯಾಗಿ ಓದಿರಿ. ಇದರಲಿಿ ಬರೆದಿರಸವ ವಿಷಯ ಅಥವಾ ಭಾಷೆ ನಿಮಗೆ ಅಥಿವಾಗದಿದ್ಲಿಿ ನಿಮಮ
ಅಧ್ಾಯಯನಕಾರರ ಬಳಿ ದಯವಿಟ್ಸು ಚರ್ಚಿಸಿ. ನಿೀವು ಸ್ವ ಇಚ್ೆೆಯಂದ ಇದರಲಿಿ ಭಾಗವಹಿಸ್ಲಸ ನಿಧ್ಿರಿಸಿದರೆ ಈ
ಹಾಳೆಗೆ ಸ್ಹಿ ಹಾರ್ಕರಿ.
ಈ ಅಧ್ಯಯನದ ಉದೆ್ೀಶ:
ಜಾಸಿೂ ತತಕ ಮತಸೂ ಧ್ಡತತಿ ದೆೀಹ ಉಳ್ಳವರಲಿಿ ಎಪಿಕಾರ್ಡಿಯಲ್ ಅರ್ಡಪೀಸ್ ಟಿಸ್ಸುವಿನ ದಪಪ( ಹೃದಯದ
ಸ್ಸತೂಲಿರಸವ ಕೆತಬಸು) ವಿನ ಪಭಾವ ಸ್ಬ್ ಮ್ಾಯರ್ಕುಮಲ್ ಕಾರ್ಡಿಯಕ್ ಔಟ್ ಪುಟ್ ಹೃದಯದ ಕೆಲಸ್ ವಾಯಯಮದ
ನಂತರ ತಿಳಿಯಲಸ ಈ ಅಧ್ಯಯನವನಸು ಮ್ಾಡಲಾಗಸತೂದೆ ಎಂದಸ ನನಗೆ ತಿಳಿದಿದೆ.
ಇದರಲಿಿ ಯಾರೆಲಿ ಭಾಗವಹಿಸ್ಬಹಸದಸ:
18 ರಿಂದ 45 ವಷಿಗಳ್ ನಡಸವೆ ದೆೀಹದ ರ್ಾರ್ಡಮ್ಾಸ್ ಇಂಡೆಕ್ು 24.9 kg/m2 ಗಿಂತ ಜಾಸಿೂ ಇರಸವವರಸ ಮತಸೂ
ಯಾರಸ ವಾಯಯಮವನಸು ವಾರದಲಿಿ 3 ಸ್ಲ ಮ್ಾಡಸತ್ಾೂರೆತೀ ಅವರಸ ಭಾಗವಹಿಸ್ಸವರಸ.ಯಾವುದೆೀ ಮ್ಾಂಸ್ಖಂಡ,
ಎಲಸಬಿನ ತ್ೆತಂದರೆ ಗಳ್ು ಮತಸೂ ಶ್ಾವಸ್ಕೆತೀಶದ ತ್ೆತಂದರೆಗಳಿಂದ ಬಳ್ಲಸತಿೂರರ್ಾರದಸ ಮತಸೂ ಯಾವುದೆೀ
ಔಷಧ್ವನಸು ಸೆೀವಿಸ್ರ್ಾರದಸ.
ಮ್ಾಡಸವ ವಿಧ್ಾನ:
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ನನಗೆ ಚ್ೆನಾುಗಿ ತಿಳಿದಿದೆಯೀನೆಂದರೆ ನಾನಸ ಎಕೆತಕಾರ್ಡಿಯೀಗರಫಿ, 20 ನಿಮಿಷಗಳ್ ವಾಯಯಮ, ಅದರಲಿಿ 5 ನಿಮಿಷ
ವಾಮ್ಿ ಅನ್್ ಟ್ೆರಡ್ ಮಿಲ್ ನ ಮೀಲೆ ನನಗೆ ಸ್ಸಸಾೂಗಸವವರೆಗೆ ಅಥವಾ , ನಾನಸ ಉಪಯೀಗಿಸ್ಸವ ರಿೀತಿಯ
ಪರಕಾರ 10 ನಿಮಿಷ, ಅದರ ಮೊದಲಸ 2 ನಿಮಿಷ ಟ್ೆರಡ್ ಮಿಲ್ ನ ಮೀಲೆ ಅಭಾಯಸ್ / ಪರಯತು. ಆದರಿಂದಾಗಿ
ಸ್ರಿಯಾದ ರಿೀತಿ ತಿಳಿಯಲಸ ಅದರ ನಂತರ ಪುನಃ ಎಕೆತಕಾರ್ಡಿಯೀಗರಫಿ ಅಳ್ತ್ೆಗಳ್ನಸು ಅದೆೀ ಮೊದಲಿನ ಸ್ಥಳ್ದಲಿಿ
ಮ್ಾಡಲಸ, ನಂತರ ಅಳ್ತ್ೆಯಾದ ಮೀಲೆ 5 ನಿಮಿಷ ಕತಲ್ ಡೌನ್ ವಾಯಯಮಗಳ್ನಸು ಮ್ಾಡಲಸ ತಯಾರಿದೆ್ೀನೆ.
ಈ ಅಧ್ಯಯನದಲಿಿ ನಿಮಮ ಪಾತರ / ಜವರ್ಾ್ರಿ:
ಈ ಅಧ್ಯಯನದಲಿಿ ಭಾಗವಹಿಸ್ಸವವರ ಪಾತರ.
1. ಕೆೀಳಿದಾಗಲೆಲಿ ಸ್ರಿಯಾದ ಮ್ಾಹಿತಿಗಳ್ನಸು ನಿೀಡಸವುದಸ.
2. ಅಧ್ಯಯನಕಾರರ ಸ್ತಚನೆ ಗಳ್ನಸು ಪಾಲಿಸ್ಸವುದಸ.
3. ನಿೀವು ಈ ಅಧ್ಯಯನದಿಂದ ಹೆತರಬರಸವುದಾದರೆ ಅಧ್ಯಯನಕಾರರಿಗೆ ತಿಳಿಸ್ರ್ೆೀಕಾಗಸವುದಸ.(ಈ ಅಧ್ಯಯನದಿಂದ
ಹೆತರಬರರ್ೆೀಕಾದರೆ ಅಧ್ಯಯನಕಾರರಿಗೆ ತಿಳಿಸಿ)
ತ್ೆತಂದರೆ ಮತಸೂ ಅನಾನಸಕತಲ:
ವಾಯಯಾಮ ಮ್ಾಡಸವಾಗ ಏಕಾಂತತ್ೆಯನಸು ಕೆತಡಲಾಗಸತೂದೆ. ಯಾಕೆಂದರೆ ವಾಯಯಮವನಸು ಪೂತಿಿಗೆತಳಿಸ್ಸವ
ಮತದಲೆೀ ಸ್ಸಸಾೂದರೆ ಯಾವುದೆೀ ಸ್ಮಯದಲಿಿ ವಾಯಯಮ ಮ್ಾಡಸವುದನಸು ನಾನಸ ನಿಲಿಿಸ್ಬಹಸದೆಂದಸ ನನಗೆ
ಹೆೀಳಿರಸತ್ಾೂರೆ.
ಲಾಭಗಳ್ು ನನಗೆ ತಿಳಿದಿದೆಯೀನೆಂದರೆ ನಾನಸ ಈ ಅಧ್ಯಯನದ ಭಾಗವಾದರೆ, ನನು ಹೃದಯದ ಕೆಲಸ್ ಎಷಸು
ಉತೂಮವಿದೆ ಎಂದಸ ತಿಳಿಯಸತೂದೆ ಮತಸೂ ಹೃದಯದ ಕೆಲಸ್ ಸ್ರಿಇಲಿದಿದ್ರೆ ನಾನಸ ವಾಯಯಮಗಳ್ನಸು ಕರಮಬದ್ವಾಗಿ
ರ್ಚರ್ಕತುಕ ಮ್ಾಗಿದಶಿನದಲಿಿ ಮಸಂದಸವರೆಸ್ಸತ್ೊೀನೆ. ಮತಸೂ
ನನು ಹೃದಯದ ಸಾಮಥಯಿವನಸು ಹೆರ್ಚೆಸ್ಸತ್ೊೀನೆ.
ಗೌಪಯತ್ೆ:
ಈ ಅಧ್ಯಯನವನಸು ಮ್ಾರ್ಡಸ್ಸತಿೂರಸವವರಲಿಿ ಗೆತತಸೂಪರ್ಡಸಿದವರಸ ಅಥವಾ ಅವರ ಪರತಿನಿಧಿ ಮತಸೂ ದಿಢಿರ್ ಕಮಿಟಿ
ಅಥವಾ ರೆಗಸಲೆೀಟ್ರಿ ರ್ಾರ್ಡಸ್ ಪತಿನಿಧಿ ಮ್ಾತರ ಈ ಅಧ್ಯಯನದ ನಿಮಮ ಹೆಸ್ರಸ, ವಿಳಾಸ್, ಮರ್ಡಕಲ್ ಮ್ಾಹಿತಿಗಳ್ು,
ಪರಿಕ್ಷೀಯ ವರದಿಗಳ್ು, ಬಂದ ಫಲಿತ್ಾಂಶಗಳ್ನಸು ಪರಿಶೀಲಿಸ್ಬಹಸದಸ. ಈ ಅಧ್ಯಯನದ ವಿವರ ಮತಸೂ
ಫಲಿತ್ಾಂಶಗಳ್ನಸು ನಿಮಮ ಹೆಸ್ರ ಗಸರಸತಸ ಇಲಿದೆ ಪರತಿಗಳ್ಲಿಿ ಪರಕಟಿಸ್ಬಹಸದಸ.
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ಅಧ್ಯಯನದಿಂದ ದೆತರೆತ ಹೆತಸ್ ವಿಷಯ:
ಈ ಅಧ್ಯಯನದಿಂದ ದೆತರೆತ ಹೆತಸ್ ವಿಷಯವನಸು ನಿೀವು ಅಧ್ಯಯನದಲಿಿ ಮಸಂದಸವರಿಯಲಸ ಅದಸ ಪರಭಾವ
ಬಿೀರಸತ್ಾೂದರೆ ಅದನಸು ನಿಮಗೆ ತಿಳಿಸ್ಲಾಗಸತೂದೆ.
ಇಲಿಿ ಸ್ಂಗರಹಿಸಿದ ಅಂರ್ಕಅಂಶಗಳ್ನಸು ಪತಿರಕೆಗಳ್ಲಿಿ ಪರಕಟಿಸ್ಲಾಗಸತೂದೆ. ನನು ಅನಸಮತಿ ಇಲಿದೆ ಯಾವುದೆೀ ಹೆಸ್ರಸ,
ಫೀಟ್ೆತಗಳ್ು ಮತಸೂ ನನು ವಿೀರ್ಡಯ ರ್ಚತಿರೀಕರಣಗಳ್ನಸು ಪರಕಟಿಸ್ಸವುದಿಲಿ.
ಈ ಅಧ್ಯಯನದಲಿಿ ಭಾಗವಹಿಸ್ಲಸ ಆಗಸವ ಖಚಸಿ:
ಈ ಅಧ್ಯಯನದಲಿಿ ಬಳ್ಸ್ಲಾಗಸವ ಪರಿೀಕ್ಷೆಗಳಿಗೆ ನಿಮಗೆ ಶಸಲಕವನಸು ವಿಧಿಸ್ಲಾಗಸವುದಿಲಿ.
ಸ್ವ ಇಚ್ೆೆಯಂದ ಭಾಗವಹಿಸ್ಸವಿಕೆ:
ಅಧ್ಯಯನದಲಿಿ ಭಾಗವಹಿಸ್ಸವುದಸ ನಿಮಮ ಸ್ವ ಇಚ್ೆೆಯಂದ ನಿೀವು ಈ ಅಧ್ಯಯನಕೆಕ ಸ್ವ ಇಚ್ೆೆಯಂದ ಬಂದವರಾದರೆ
ಯಾವುದೆೀ ಸ್ಮಯದಲಿಿ ಏನತ ಕಾರಣ ಕೆತಡದೆ ಇದರಲಿಿ ಭಾಗವಹಿಸ್ಸವುದನಸು ನಿಲಿಿಸ್ಲಸ ನಿಮಗೆ ಹಕಸಕ ಇದೆ.
ಅಧ್ಯಯನ ನಡೆಸ್ಸವವರಸ ಮತಸೂ ಅಧ್ಯಯನ ಮ್ಾಡಸವವರಸ ಏನತ ಕಾರಣ ಕೆತಡದೆ ನಿಮಮ ಅನಸಮತಿ ಇಲಿದೆ
ಯಾವುದೆೀ ಸ್ಮಯದಲಿಿ ನಿೀವು ಭಾಗವಹಿಸ್ಸವುದನಸು ನಿಲಿಿಸ್ಬಹಸದಸ.
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ಅನುಮತಿ ಪತ್ರ
ಅಧ್ಯಯನದ ಶೀರ್ಷಿಕೆ: ರಿಲೆೀಶನ್ ಶಪ್ ಬಿಟಿವೀನ್ ಎಪಿಕಾರ್ಡಿಯಲ್ ಅರ್ಡಪೀಸ್ ಟಿಸ್ಸು ತಿಕ್ ನೆಸ್ು ವಿದ್ದ್
ಕಾರ್ಡಿಯಾಕ್ ಔಟ್ ಪುಟ್.
ಭಾಗವಹಿಸ್ಸವವರ ಹೆಸ್ರಸ:
ಭಾಗವಹಿಸ್ಸವವರ ವಯಸ್ಸು:
ಅಧ್ಯಯನದಲಿಿ ಭಾಗವಹಿಸ್ಸವವರ ಬಗೆಗಿನ ವಿವರಗಳ್ನಸು ಓದಿದೆ್ೀನೆ ಮತಸೂ ಅವುಗಳ್ನಸು ನನಗೆ ಚ್ೆನಾುಗಿ
ವಿವರಿಸಿದಾ್ರೆ. ಪಶ್ೆುಗಳ್ನಸು ಕೆೀಳ್ಲಸ ಮತಸೂ ಸ್ಮ್ಾಧಿ ನಕರ ಉತೂರಗಳ್ನಸು ತಿಳಿಯಲಸ ಅವಕಾಶವಿತಸೂ.
ಈ ಅಧ್ಯಯನದಲಿಿ ಭಾಗವಹಿಸ್ಸವುದಸ ನನು ಸ್ವ ಇಚ್ೆೆಯಂದ ಮತಸೂ ಇದರಿಂದ ಹಿಂತ್ೆಗಿತ ಯಾವುದೆೀ ಕಾರಣ ನಿೀಡದೆ
ಮ್ಾಡಲಸ ನನಗೆ ಹಕಸಕ ಇದೆ. ಇದರಿಂದ ನನು ಕನತನಸಬದ್ ಹಕಸಕಗಳ್ು ಅಥವಾ ನನಗೆ ಕೆತಡಲಗಸವ ಆಸ್ಪತ್ೆರಯ
ಸೌಲಭಯಗಳಿಗೆ ಧ್ಕೆಕಯಾಗಸವುದಿಲಿ. ನಾನಸ ಈ ಅಧ್ಯಯನದಲಿಿ ಭಾಗವಹಿಸ್ಲಸ ಸ್ಮಮತಿಸ್ಸತ್ೊೀನೆ. ತ್ಾರಿೀಕಸ ಮತಸೂ
ಸ್ಹಿ ಹೆತಂದಿರಸವ ಅನಸಮತಿ ಪತರದ ಜೆತತ್ೆ ಭಾಗವಹಿಸ್ಸವವರ ಬಗೆಗಿನ ವಿವರಗಳಿರಸವ ಹಾಳೆಯನಸು ನಾನಸ
ಪಡೆದಿದೆ್ೀನೆಂದಸ ನಾನಸ ಧ್ೃಢಪರ್ಡಸ್ಸತ್ೊೀನೆ.
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ಭಾಗವಹಿಸ್ಸವವರ ಸ್ಹಿ
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ಭಾಗವಹಿಸ್ಸವವರ ಹೆಸ್ರಸ
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ತ್ಾರಿೀಖಸ
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ತ್ಾರಿೀಖಸ
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ಸಾಕ್ಷದಾರರ ಹೆಸ್ರಸ ಮತಸೂ ಸ್ಹಿ
ತ್ಾರಿೀಖಸ
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ಅನಸಮತಿಯನಸು ವಿವರಿಸ್ಸತಿೂರಸವವರ ಸ್ಹಿ
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ಅನಸಮತಿಯನಸು ವಿವರಿಸ್ಸತಿೂರಸವವರ ಹೆಸ್ರಸ
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ತ್ಾರಿೀಖಸ
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ತ್ಾರಿೀಖಸ
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