Download MD General Medicine Department of General Medicine, AJ

Date:15 t h
September 2013
From,
Dr. Kevin Abraham Chacko,
Junior resident,
Department of General Medicine,
A.J. Institute of Medical Sciences,
Kuntikana, Mangalore.
To,
The Chairman/ Member Secretary
Institute Ethics Committee,
A.J. Institute of Medical Sciences,
Kuntikana, Mangalore.
Through the Head of the department of General Medicine
Subject: Submission of synopsis to Ethical committee-reg.
I am herewith submitting my MD dissertation synopsis titled “STUDY TO ASSESS THE
PROPORTION AND RISK FACTORS OF INTRACEREBRAL HEMORRHAGE
VERSUS ISCHEMIC STROKE IN A.J. INSTITUTE OF MEDICAL SCIENCES AND
A.J.HOSPITAL AND RESEARCH CENTRE” for the consideration of the Institute Ethics
committee. I have also enclosed the proforma for the ethics committee, data collection
proforma, and curriculum vitae. I request you to kindly do the needful.
Thanking you,
Yours sincerely
Dr. Kevin Abraham Chacko
1
Encl: as above
Institute Ethics Committee
A J Institute of Medical Sciences, Kuntikana, Mangalore.
Proforma to be filled by the Principal Investigator (PI) for submission to
Institutional Ethics Committee (IEC)
(for attachment to each copy of the proposal)
Serial No of IEC
Management Office:
Proposal Title: “STUDY TO ASSESS THE PROPORTION AND RISK
FACTORS OF INTRACEREBRAL HEMORRHAGE VERSUS
ISCHEMIC STROKE IN A.J. INSTITUTE OF MEDICAL SCIENCES
AND A.J. HOSPITAL AND RESEARCH CENTRE”
Principal
Investigator
Name, Designation
&
Qualifications
Address
Tel & Fax Nos.
Email ID
Dr. Kevin Abraham Chacko
Junior Resident,
Dept.of General Medicine,
A.J.Institute of Medical
Sciences.
AJ Boys Resident’s Hostel,
Room no 306
Kuntikana, Mangalore
Ph: 9902698370
[email protected]
Signature
M.B.B.S.
Guide
Dr. E.V.S Maben
304,Sundari Apartments
Professor
Shivbagh,Kadri
Dept. of General Medicine
A.J.Institute of Medical Mangalore-575002
Sciences.
M.B.B.S,
Medicine)
M.D.(General
2
Curriculum Vitae of principal investigator and the guide (with subject specific publications
limited to previous 5 years) – attached
Institute Ethics Committee
A J Institute of Medical Sciences, Kuntikana, Mangalore.
1.Type of Study: Retrospective record based study
2. Brief description of the proposal: Stroke is a global health problem and is a leading cause of
adult disability. India, with more than 1 billion inhabitants, is undergoing remarkable economic
and demographic changes in recent years resulting in a transition from poverty-related infectious
and nutritional deficiency diseases toward lifestyle-related cardiovascular and cerebrovascular
diseases.
3. Subject selection:
i.
ii.
Number of Subjects
: All enumerated cases during the study period will be
considered for the study.
Duration of study
: 4 years
iii.
iv.
Will subjects from both sexes be recruited:
Inclusion / exclusion criteria given:
v.
Type of subjects: All cases of first onset stroke patients admitted to A.J.
HOSPITAL.
Yes
Yes
4. Privacy and confidentiality
Confidential handling of data : Yes
3
5. Consent :
not required.
Institute Ethics Committee
A J Institute of Medical Sciences, Kuntikana, Mangalore.
6. Will any advertising be done for recruitment of Subjects?
(posters, flyers, brochure, websites – if so kindly attach a copy)
No
7. Risks & Benefits: No risks, but benefits to the research world
8. Is there compensation for participation?
No
Checklist for attached documents:
1.
2.
3.
4.
Place:
Date:
Project proposal – 2 Copies
Curriculum Vitae of Investigators
Curriculum Vitae of Guide
Copy of data collection Proforma
Signature & Designation of
Principal investigator
4
CURRICULAM VITAE
Dr’s Name
:
Dr. Kevin Abraham Chacko
Date of Birth & Age
:
October 16th 1987, 25 years
Present Designation
:
PG
Department
:
General Medicine
College
:
A.J. Institute of Medical Sciences
City
:
Mangalore
Residential Address
:
AJ Boys Resident’s Hostel,
Room no 306, Kuntikana,
Mangalore.
Phone Number
:
Mobile No
:
E-mail address:
9902698370
[email protected]
Qualifications:
Qualifications College
MBBS
University
Pushpagiri
M.G.
Institute of University
Medical
Sciences and
Research
Centre,
Thiruvalla,
Kerala.
Year
November
2011
Registration
No. of UG &
PG with date
44281,
Date
January 11,
2012.
Name of the
Medical
Council
TravancoreCochin
Medical
Council
To
DD/MM/YY
Total
experience in
years
&
months
Details of pervious appointments/teaching experience
Designation
Department
Name
of From
Institution
DD/MM/YY
PG
General
Medicine
A.J.
June10, 2013 Till Date
Institute of
Medical
Sciences,
Mangalore
5
CURRICULAM VITAE
Name
:
DR.E.V.S Maben
Date of birth & Age
:
Dec 03, 1962- 50 Years
Present Designation
:
Professor and HOD
Department
:
General Medicine
College
:
A.J. Institute of Medical Sciences
City
:
Mangalore
Residential Address
Phone & Fax Number with code
:
304,Sundari Apartments,
Shivbagh,Kadri
Mangalore-575003
:
1. Date of joining present institution:
Office
:
0824-2225533
Residence
:
0824-2217367
Mobile number
:
9845080872
April 16, 2004 as Associate Professor
2. Qualifications:
Qualification
College
University
Year
MBBS
Kasturba
Medical
College,
Mangalore
Kasturba
Medical
College,
Mangalore
Mangalore
University
July 1986
Mangalore
University
Dec 1990
MD
(General
Medicine)
DM/M.Ch
Registration
No.of UG &
PG with date
26451,
dt.sep09,1987
Name of the
State Medical
Council
Karnataka
Medical
council
26451,
dt.June
20,2000
Karnataka
Medical
council
NA
6
CURRICULAM VITAE
Details of the previous appointments /teaching experience
Designation
Department
Name
of Institution
From
DD/MM/YY
To
DD/MM/YY
Tutor/
Resident
General
Medicine
Jan 1988
Dec 1990
Lecture
General
Medicine
Mar 15, 1991
Mar 14, 1991
3 years
Assistant
Professor
General
Medicine
March 15,
1991
March 14,
1953
7
years,9
months
Associate
Professor
General
Medicine
Kasturba
Medical
College,
Mangalore
Kasturba
Medical
College,
Mangalore
Kasturba
Medical
College
Mangalore
Kasturba
Medical
College
Mangalore
Total
Experience
in
years
and
months
3 Years
Dec 19,2000
April 15,2004
3 Years 4
months
Dec 17,2004
8 months
Apr 16,2004
A.J Insitute
Of Medical
Sciences,
Mangalore
Professor
General
Medicine
Professor & General
HOD
Medicine
3 Years 6
months
A.J
Dec 18,2004
Institute of
Medical
Sciences,
Mangalore
A.J
Jun 22, 2008
Institute of
Medical
Sciences,
Mangalore
June 21,2008
Till date
5 years
7
SYNOPSIS
Submission for ethical clearance to Ethical Committee of AJIMS
“STUDY TO ASSESS THE PROPORTION AND RISK FACTRS OF
INTRACEREBRAL HEMORRHAGE VERSUS
ISCHEMIC STROKE
IN A.J. INSTITUTE OF MEDICAL SCIENCES AND A.J. HOSPITAL
AND RESEARCH CENTRE”
Name of the candidate
Guide
Course and Subject
: Dr. Kevin Abraham Chacko
: Dr.E.V.S Maben
: M.D. General Medicine
Department of General Medicine ,
A.J. INSTITUTE OF MEDICAL SCIENCES,
Kuntikana, Mangalore – 575004
2013
8
1. Name of the candidate
Dr. KEVIN ABRAHAM CHACKO,
& address:
POSTGRADUATE STUDENT,
(In block letters)
DEPT. OF GENERAL MEDICINE,
A J INSTITUTE OF MEDICAL SCIENCES,
NH-17, KUNTIKANA,
MANGALORE – 575004.
2. Name of the Institute:
A J INSTITUTE OF MEDICAL SCIENCES,
NH-17, KUNTIKANA,
MANGALORE – 575004.
3. Course of study and Subject: M.D. GENERAL MEDICINE
4. Date of admission to course:
10 t h JUNE 2013
5. Title of the Topic: “STUDY TO ASSESS PROPORTION AND
RISK FACTORS OF INTRACEREBRAL HEMORRHAGE
VERSUS ISCHEMIC STROKE IN A.J.INSTITUTE OF
MEDICAL SCIENCES AND A.J. HOSPITAL AND RESEARCH
CENTRE”
9
BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Stroke is a global health problem and is a leading cause of adult disability. Of 35
million deaths attributable to chronic non-communicable diseases that occurred worldwide in
2005, stroke was responsible for 5.7 million (16.6%) deaths, and 87% of these deaths
occurred in low-income and middle-income countries2
 India, with more than 1 billion inhabitants, is undergoing remarkable economic and
demographic changes in recent years resulting in a transition from poverty-related
infectious and nutritional deficiency diseases toward lifestyle-related cardiovascular
and cerebro-vascular diseases2
 Driven by increasing size and aging of populations, and escalating prevalence of risk
factors such as hypertension, tobacco use, unhealthy diet, physical inac- tivity, and
obesity, stroke is becoming a major cause of premature death and disability in
developing countries2

Given the anticipated increase in burden of stroke in coming years and limited
availability of organized stroke care services to the majority of people in India, it
would be logical to place greater emphasis on population- based stroke prevention
strategies. However, very little reliable information is currently available regarding
epidemiology of stroke in India. The reported frequency, pattern, risk factors, and
outcome of stroke from India are largely derived from hospital-based observations2
 Although the pattern of risk factors for stroke has been intensively investigated, it is
important to know if risk factors are the same in different areas of the world and whether
the relative importance of the risk factors varies.

Incidence studies of ischemic stroke subtypes could provide investigators with the
opportunity to quantify the societal stroke burden attributable to specific mechanisms of
stroke, explore sex and race differences in stroke etiology, and more accurately define
the frequency of various stroke risk factors among stroke subtypes.
10
 6.2 Review of literature :
A stroke or cerebro-vascular accident , is defined by an abrupt onset of a neurological deficit that is
attributable to a focal vascular cause1
The diagnosis of stroke is clinical and laboratory studies including brain imaging are used to support
the diagnosis.

Cerebral ischemia is usually caused by thrombosis of the cerebral vessels themselves or by
emboli from a proximal arterial source or the heart.

Intracranial haemorrhage is caused by bleeding directly into or around the brain. It produces
neurologic symptoms by a mass effect on neural structures, from toxic effects of blood itself,
or by increasing intracranial pressure1
A similar study was done under the Trivandrum Stroke Registry to study2

Incidence, Types, Risk Factors, and Outcome of Stroke in a Developing Country.

Methods used— They recorded all first-ever strokes occurring among 741 000 urban and 185
000 rural inhabitants of Trivandrum, Kerala.

Results of the study— During a 6-month period, 541 strokes were registered, 431 in the urban
and 110 in the rural communities. Stroke occurred at a median age of 67 years; only 3.8% of
patients were aged 40 years. Adjusted annual incidence rates per 100 000 were 135 urban,
and 138 for rural populations, and 74.8 (66.3 to 83.2), 10.1 (7.0 to 13.2), and 4.2 (2.2 to 6.1)
for ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage, respectively.
There was more stroke of undetermined type in the rural community.

Conclusions—There are more similarities than differences between developing and developed
countries in the epidemiology of stroke2
Another study was done in Copenhagen , Denmark3

Stroke incidence in Copenhagen, Denmark was recorded in a random population sample of
19,327 persons invited for two health examinations with 5 years' interval from 1976 to 1983.
Stroke incidence increased exponentially with age.

The estimated incidence of first stroke was 1.41/ 1000 women and 2.48/1000 men; the total
incidence was 1.94/1000 population. Risk factor analysis was based on the initial examination
of 13,088 persons >35 years old without previous stroke who responded to the first invitation,
in whom 295 first strokes were subsequently observed. Among the 16 potential risk factors
for stroke we examined, significant effects were found for age, sex, household income,
smoking habits, systolic blood pressure, diabetes, plasma cholesterol concentration, ischemic
heart disease, and atrial fibrillation. No significant effect could be demonstrated for a positive
11
family history of stroke, years of school education, marital status, alcohol consumption, daily
use of tranquilizers, body mass index, or postmenopausal hormone treatment3
A population based study on the incidence and risk factors of ischemic stroke was carried out in
Rochester4

In the study they identified all 454 residents of Rochester, with a first ischemic stroke
between 1985 and 1989 from the Rochester Epidemiology Project medical records linkage
system. They used Stroke Data Bank criteria to assign infarct subtypes after reviewing
medical records and brain imaging. They adjusted average annual incidence rates by age and
sex to the US 1990 population and compared the age-adjusted frequency of stroke risk factors
across ischemic stroke subtypes.

Results—Age- and sex-adjusted incidence rates (per 100 000 population) were as follows:
large-vessel cervical or intracranial atherosclerosis with .50% stenosis, 27; cardio-embolic,
40; lacuna, 25; uncertain cause, 52; other or uncommon cause, 4. Sex differences in incidence
rates were detected only for atherosclerosis with stenosis (47 [95% CI, 34 to 61] for men; 12
[95% CI, 7 to 17] for women). There was no difference in prior transient ischemic attack and
hypertension among subtypes, and diabetes was not more common among patients with
lacunar infarction than other common subtypes.

Conclusions—The age-adjusted incidence rate of stroke due to stenosis of the large
cervicocephalic vessels is nearly 4 times higher for men than for women. There is no
association between preceding transient ischemic attack and stroke mechanism. Diabetes and
hypertension are not more common among patients with lacunae. Age- and sex-adjusted
incidence rates for ischemic stroke subtypes in this population can be compared with similarly
determined rates from other populations4
Another study done gave a systematic overview of

Case-control and cohort studies on risk factors for ICH.

Methods—they searched MEDLINE, LILACS, EXTRAMED, and Pascal from 1966 to 2001
to identify studies. Studies were included if they met predefined methodological criteria.
Summary odds ratios (ORs) were calculated for case-control studies, and summary relative
risks (RRs) were found for cohort studies and for case-control and cohort studies combined.

Results—Fourteen case-control and 11 cohort studies were identified. They could not
always combine the results of case-control and cohort studies. In cohort studies, the crude
RR for age (every 10-year increase) was 1.97 (95% confidence interval [CI], 1.79 to 2.16). In
case-control studies, the crude OR for high alcohol intake was 3.36 (95% CI, 2.21 to 5.12)
and for hypertension was 3.68 (95% CI, 2.52 to 5.38). Two cohort studies showed an
12
increasing risk of ICH with increasing degree of hypertension. In cohort and case-control
studies combined, the crude RR for sex (male versus female) was 3.73 (95% CI, 3.28 to
4.25); for current smoking, 1.31 (95% CI, 1.09 to 1.58); and for diabetes, 1.30 (95% CI, 1.02
to 1.67). Conclusions—Risk factors for ICH appeared to be age, male sex, hypertension, and
high alcohol intake. High cholesterol tends to be associated with a lower risk of ICH5
Findings suggest that morbidity and mortality associated with ischemic stroke can be predicted by
various clinical indicators, some of which may be amenable to intervention6
In the Middle East and North Africa (MENA), stroke is progressively becoming a major health
problem and it is estimated that its current mortality will double by 2030. Incidence rate of stroke and
its case fatality rate varies extensively among studies in this region . In this respect, the prevention
strategies need to be implemented urgently7
Prospective studies have revealed different risk factors for stroke subtypes. The risk factors for
ischemic stroke include aging, hypertension, diabetes, smoking, history of cardiovascular diseases
(CVD) , atrial fibrillation, and left ventricular hypertrophy. The study also demonstrated the stronger
effect of chronic kidney disease (CKD) on stroke among Asian populations compared to non-Asian
populations7
In a study conducted in Karachi8
Patients with acute ischemic stroke were enrolled. Studied variables included demographic
profile, history of risk factors, physical and neurological examination, and investigations relevant
with the objectives of the study. Findings were described as frequency percentages.
Results: Out of the 100 patients with acute ischemic stroke, mean age at presentation was 63.5
years. Risk factor distribution was hypertension in 85%, Diabetes mellitus in 49%, ischemic heart
disease in 30%, dyslipidemia in 22%, smoking in 9%, atrial fibrillation in 5%, and previous
history of stroke in 29%. The various subtypes of acute ischemic stroke were lacunar infarct in
43%, large artery atherosclerosis in 31%, cardioembolic type in 8%, stroke of other determined
etiology in 1% and stroke of undetermined etiology in 18%. Hypertension and Diabetes were the
most important risk factors in both large and small artery atherosclerosis. In patients with cardioembolic stroke significant association was found with ischemic heart disease (p=0.01)
13
6.3 Objectives of the study :
 To study the proportion of intra -cerebral hemorrhage versus ischemic
stroke in A.J. Institute of Medical Sciences and A.J. Hospital and
Research Centre .
 To assess the risk factors in each.
 To anal yse the trend in proportion and risk factors of each.
7. Material and methods:
7.1 Source of data.
It will be a Retrospective Record based hospital study, comprising of patients diagnosed for
the first time with intra-cerebral hemorrhage or ischemic stroke from A.J. Hospital,
Mangalore.
7.2 Method of collection of data (including sampling procedure, if any)
Sample and sampling technique :

Study design: Four year Retrospective study.

Set-up: AJ INSTITUTE OF MEDICAL SCIENCES AND AJ HOSPITAL AND
RESEARCH CENTRE.

Study Period: July 2009 up to July 2013.

Age group: 20 years and above.

All the first ever diagnosed cases of intra-cerebral hemorrhage and ischemic strokes
admitted to A.J. Hospital.
Study type: Four year retrospective study.
Inclusion criteria:`
.
First ever stroke.
•
Neurological
deficit
conformed
by
clinical
examination
and
radiological imaging[ either CT BRAIN or MR I]
•
Patients who expired during the study period with cause of death
related to stroke.
14
•
Diagnosed cases of HTN, DM and IHD with stroke.
Exclusion criteria:

TIA

Cases of SAH, Seizure disorders, or malignancies producing stroke.

Post -operative patients.

ICH due to trauma.

Patients who died within 24 hours of hospitalisation without radiological evidence
of stroke.
Plan for data analysis:
The various measures of central tendencies and graphical representations will be used to
analyze the data using SPSS software.
7.3 Does the study require any investigations or interventions to be
conducted on patients or other humans or animals? If so, please describe
briefly.
No
7.4 Has ethical clearance been obtained from your institution in case of 7.
Ethical clearance obtained.
15
8 . References
1. Longo DL, Fauci AS, Jameson JL, Hauser SL, Loscalzo J, Kasper DL,
editors.Harrison’s principles of internal medicine 18th edition. U.S.A: McGraw-Hill;
2012. vol 2; p. 3270-3299.
2. Sridharan SE, Unnikrishnan JP, Sukumaran S, Sylaja PN, Nayak SD, Sankara P, et al.
Trivandrum Stroke Registry. Journal of American Heart Association.2009;40:1212-1218.
3. Boysen G, Nyboe J, Appleyard M, Sørensen PS, Boas J, Somnier F, et al. Stroke incidence
and risk factors for stroke in Copenhagen, Denmark. Journal of American Heart
Association.1988;19:1345-1353.
4. Petty GW, Brown RD, Whisnant JP, Sicks JD, Fallon WM, Wiebers DO. Ischemic Stroke
Subtypes: A Population-Based Study of Incidence and Risk Factors. Journal of the
American Heart Association.1999;30:2513-2516.
5. Ariesen MJ, Claus SP, Rinkel GJE, Algra A. Risk Factors for Intracerebral
Hemorrhage in the General Population: A Systematic Review. Journal of American
Heart Association.2003;34:2060-2065.
6. Simons LA, McCallum J, Friedlander Y, Simons J. Risk factors for ischemic stroke:
Dubbo Study of the elderly. University of New South Wales Lipid Research
Department, St.Vincent's Hospital, Sydney, NSW, Australia.1998 Jul;29(7):1341-6.
7. Khalili D, Mohebi R, Azizi F, Hadaegh F. Risk factors for ischemic stroke; results
from 9 years of follow-up in a population based cohort of Iran. BMC
Neurology 2012; 12:117.
16
8. Yao X, Lin Y, Geng J, Sun Y, Chen Y, Shi G,et al. Age and Gender-Specific
Prevalence of Risk Factors in Patients with First-Ever Ischemic Stroke in China.
China Stroke Research and Treatment Volume 2012 (2012), Article ID 136398, 6
pages.
9. Aquil N , Begum I , Ahmed A , Vohra EA, Soomro BA.
Risk Factors in Various Subtypes of Ischemic Stroke According to TOAST Criteria .
Journal of the College of Physicians and Surgeons Pakistan.2011, Vol. 21 (5): 280-28
9. Signature of the candidate:
10. Remarks of the guide :
11. Name and Designation of (in block letters) :11.1 Guide:
DR.E.V.S MABEN MD,
PROFESSOR,
DEPARTMENT OF GENERAL MEDICINE,
A J INSTITUTE OF MEDICAL SCIENCES,
MANGALORE – 575004.
11.2 Signature:
11.3 Head of Department:
DR. E V S MABEN MD,
PROFESSOR & HEAD
DEPARTMENT OF GENERAL MEDICINE,
A J INSTITUTE OF MEDICAL SCIENCES,
MANGALORE – 575004.
17
11.4 Signature:
12. Remarks of the Chairman and Principal :
12.2 Signature:
18
Proforma:
Case no. :
Name:
Age:
Sex:
Address:
Occupation:
Religion:
Socio-economic status: Upper class / Middle Class / Lower class.
Clinical information: Findings at onset
u/l or b/l sensory impairment - Y/N
hemianopia
-Y/N
apraxia of acute onset
-Y/N
perception deficit of a/c onset -Y/N
Other:
dizziness/vertigo
diplopia
dyshpagia
O.P. No. / I.P. No.
Dept / Ward
Unit:
Date of Admission:
Date of discharge
, aphasia/dysphasia
-Y/N
, forced gaze
-Y/N
, ataxia of acute onset
-Y/N
, u/l or b/l motor impairment -Y/N
localised headache
dysarthria
impaired cognition
blurring of vision
impaired consciousness
Past history: HTN, DM, Dyslipidemia, IHD.
Family history: h/o of stroke.
Personal history: Current tobacco use, alcohol consumption.
Drug history:
Imaging studies:
CT-BRAIN
MRI
Diagnosis:
Vital Status:
If dead:
Cause of death:
clinical + CT
clinical + MRI
alive
dead
dateplace (either hospital or not)related to stroke or not-
FOLLOW UP AND RESULTS:
19