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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE,
KARNATAKA
Synopsis of Dissertation
ROLE OF COLOUR DOPPLER SONOGRAPHY IN THE EVALUATION OF VASCULAR
DISEASES OF THE EXTRA CRANIAL CAROTID VESSELS
Submitted by:
Dr. VINAY SAGAR K, MBBS
Post Graduate Student in Radiodiagnosis
Department of Radiodiagnosis
Adichunchanagiri Institute of Medical Sciences,
B.G. Nagar, Nagamangala Taluk, Mandya District -571 448
1
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DESSERTATION
(In block letters)
DR. VINAY SAGAR. K.
DEPARTMENT OF RADIODIAGNOSIS
AIMS, B.G.NAGARA 571448
2.
NAME OF THE INSTITUTION
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.
3.
COURSE OF STUDY AND SUBJECT
M.D (RADIODIAGNOSIS)
4.
DATE OF ADMISSION TO COURSE
1ST JUNE 2008
5.
TITLE OF THE TOPIC
6.
BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE:
6.3 OBJECTIVES OF THE STUDY
7.
MATERIALS AND METHODS
APPENDIX – II
7.1 SOURCE OF DATA
APPENDIX – II A
7.2 METHOD OF COLLECTION OF DATA:
(INCLUDING SAMPLING PROCEDURE IF
ANY)
APPENDIX – II B
7.3 DOES THE STUDY REQUIRE ANY
INVESTIGATIONS OR INTERVENTIONS
TO BE CONDUCTED ON PATIENTS OR
OTHER ANIMALS, IF SO PLEASE
DESCRIBE BRIEFLY.
YES
APPENDIX –II C
7.4 HAS ETHICAL CLEARANCE BEEN
OBTAINED FROM YOUR INSTITUTION IN
CASE OF 7.3
YES
APPENDIX – II D
LIST OF REFERENCES
APPENDIX – III
1.
8.
NAME OF THE CANDIDATE AND ADDRESS
“ROLE OF COLOUR DOPPLER
SONOGRAPHY IN THE EVALUATION
OF VASCULAR DISEASES OF THE
EXTRA CRANIAL CAROTID
VESSELS”
APPENDIX – I
APPENDIX – I A
APPENDIX – I B
APPENDIX – I C
2
9.
SIGNATURE OF THE CANDIDATE
10.
REMARKS OF THE GUIDE
11.
NAME AND DESIGNATION OF
(IN BLOCK LETTERS)
11.1 GUIDE
Dissertation titled ‘‘role of colour doppler
sonography in the evaluation of vascular
diseases of the extra cranial carotid
vessels’’ being a non invasive, cost
effective imaging modality plays an
important role in early detection of various
vascular disorders of extracranial carotid
vessels including characterization of
plaques in particular -high risk patients (
HTN,DM,CAD) thereby enabling to reduce
the morbidity and mortality in general
public.
Hence I strongly recommend the said
project which may be very useful to all
types of impending strokes (young/old).
DR. B.V. BALAKRISHNA
PROFESSOR AND HEAD
DEPARTMENT OF RADIODIAGNOSIS
AIMS , B.G.NAGARA.
11.2 SIGNATURE
11.3 CO-GUIDE (IF ANY)
11.4 SIGNATURE
NIL
11.5 HEAD OF DEPARTMENT
DR. B.V. BALAKRISHNA
PROFESSOR AND HEAD
DEPARTMENT OF RADIODIAGNOSIS
AIMS , B.G.NAGARA.
11.6 SIGNATURE
12.
12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL
12.2 SIGNATURE
3
APPENDIX - I
6. BRIEF RESUME OF THE INTENDED WORK:
APPENDIX -1 A
6.1 NEED FOR THE STUDY :
Stroke syndrome constitutes an important and formidable health problem globally. The stroke
syndrome consists of the rapid development of a focal neurological deficit that is usually localised to an
area of brain supplied by a specific artery. In India surveys show hemiplegia prevalence of 200 per 1lakh
persons, nearly 1.5% of all urban hospital admission, 4.5% of medical and 20% of neurological cases.1
An estimated 80% of strokes are thromboembolic in origin, often with carotid plaque as
the embolic source.2 Atherosclerotic narrowing of the extra cranial carotid arteries, usually involves the
internal carotid artery (ICA) especially 2cm from the carotid bifurcation in 30% to 60% of the stroke
cases2 and this site is easily amenable to examination by sonography as well as surgical intervention.
Diagnosis of carotid stenosis is critical to identify those patients who would benefit from
surgical treatment , in addition ultrasound can assses the plaque morphology, for example hemorrhagic
plaque, which is known to be an independent risk factor for stroke or transient ischemic attack (TIA) .3,4
If timely atherectomies of the carotid are performed, many strokes may be prevented or salvaged.
This necessitates evaluation of extra-cranial Carotid artery system.
Colour Doppler sonography has become a main stay in evaluation of the extra cranial territory
and its accuracy in comparison with angiography is well established.5,6 The principal appealing points
in favour of sonography are patient comfort, lack of risk and accuracy. In contrast the
angiography is invasive and expensive. Moreover contrast related adverse effects also contribute
to significant morbidity.
Though the prime indication of colour Doppler sonographic examination of carotid vasculature
4
is stroke prevention, it has now-a-days ramified to evaluate various miscellaneous subjects such as
suspected patients of aneurysm, follow up of carotid dissection7,8 , chemodectoma and takayasu's
arteritis and in pulsatile neck masses and carotid tumors9,10 .
Therefore this study will enable us to find out the age, sex distribution and incidence of carotid
artery disease, in this region in patients presenting with symptoms of stroke and if atherosclerosis is
diagnosed the plaque morphology, site and progression of the disease can be noted on serial scans and
patients in need of medical / surgical management identified at an early stage and treated accordingly.
APPENDIX -I B
6.2 REVIEW OF LITERATURE :
MIYAZAKI and KATO et al -1965: first reported the use of Doppler ultrasound for the
assessment of extra cranial carotid vasculature.
BLAISDELL et al; HAGS et al and CAROLL etal-1965: demonstrated that 30-60% of
strokes are produced by atherosclerosis disease involving extra cranial arteries within 2cm of the
carotid bifurcation.
BARBER et al 1974: was first to propose the use of ultra sound for the investigation of
carotid bifurcation disease.
LANGENTHAN I.R.A 1977: contributed major advances in signal processing and was
able to develop a real time on line Fast Fourier transformation spectrum analyzer that could be
adapted to the output of pulsed Doppler duplex scanner.
5
THOMSON et al 1978: mentioned that cervical bruit can be used as marker of carotid
disease in asymptomatic patients and these patients are increased risk of TIA and stroke
BLACK SHEAR et al 1980: cited the importance of ratio of Peak Systolic velocity (PSV)
in ICA to that of CCA and found the ratio less than 1 is normal and greater than 2 corresponds to
a stenosis of approx 50%.
BRESLAU P.J.et al 1982: stated that a high grade stenosis was an occlusion which
caused high impedance signal in CCA with either absence or reversal of blood flow:
WOOD et al DREISBACH et al and GRANT et al 1983: opined that evaluation of CAD
by duplex sonography had 92-95% accuracy compared to conventional angiography. They pointed
out that the positive predictive value of the test is 97% and that is 3%false positive result.
TAYLOR D.C.; E.STRANDNESS (1987) demonstrated the Doppler sensitivity of 99% and
specificity of 84% when compared with angiography.
WILLIAM D; MIDDLETON.J et al (1988): stated that flow reversal is a normal
phenomenon and occupied 33% of carotid bulb lumen and duration is-22% of total cardiac cycle.
BLUTH E.I; KAY.D et al 1989: characterised sonographically atherosclerotic plaque and
detected hemorrhage with in plaque.
ZWIEBEL AND KNIGHTON 1990: suggested that a very fresh thrombus was virtually
anechoic and a very old thrombus was moderate to markedly echogenic.
PATEL M R; KUNTZ K M; et al 1995: opined preoperative assessment of the carotid
bifurcation by MRA and duplex sonography can replace angiography.
6
BLUTH E I ;SUNSHINE LH et al 2000:evaluated power Doppler imaging as possible
exam for screening of carotid artery stenosis and found results are comparable to efficacy of
mammography as a generally accepted screening method.
PHILIPS.C.D;BUBASH.L.A et al 2002:stressed the importance off duplex sonography in
evaluation neck vasculature in trauma.
APPENDIX -I C
6.3 OBJECTIVES OF THE STUDY:
This study concerns with
1. To evaluate the Morphological and Physiological changes those take place in extra cranial
portion of carotid arteries in patients with hemiplegia and transient ischemic attacks.
2. To evaluate the pathological variations of carotid vasculature in patients with attributable
neurological symptoms and physical signs.
3. To evaluate patients who are at increased risk of carotid artery disease. ( Diabetes Mellitus ,
Hyperlipidemia, Hypertension)
4. To compare our results of duplex sonography in evaluation of cases of carotid artery disease
with those of others experience in available literature.
5. To assess the utility of peak systolic velocity and peak systolic velocity ratio of ICA/CCA in
diagnosing carotid artery stenosis.
6. To evaluate spectral pattern of duplex in haemodynamically significant carotid artery stenosis.
7
APPENDIX- I D
6.4 INCLUSION AND EXCLUSION CRITERIA
INCLUSION CRITERIA
1. Patients (in patients or out patients) with recent onset of neurological and vascular symptoms
referred to the department of Radiodiagnosis, SAH & RC, for Colour Doppler Sonographic
examination of the extra cranial course of carotid vessels from the departments of medicine and
surgery of SAH & RC.
2. Patients of all age groups.
3. Both male and female patients.
EXCLUSION CRITERIA
1. Patients already diagnosed with carotid artery disease and on treatment either medical or who
have undergone surgical treatment.
2. Comatose or critically ill patients.
3. Patients admitted to Medical or Surgical wards and unable to be transferred to the department
of Radiodiagnosis for the investigation, due to lack of a portable colour doppler unit.
8
APPENDIX - II
7.0 MATERIALS AND METHODS
APPENDIX II - A
7.1 SOURCE OF DATA
I intend to study 80 cases either in or out patients with recent onset of neurological / vascular
symptoms referred to the department of Radiodiagnosis SAH and RC for Doppler Sonographic
evaluation of the extra cranial carotids.
APPENDIX - II B
7.2 METHODS OF COLLECTION OF DATA
The study will be conducted in SAH & RC, B.G. Nagara. The cases which will be
subjected to the present study will be patients admitted in the hospital either as inpatients or
presenting as outpatients to the departments of Medicine and Surgery and referred to the
department of Radiodiagnosis. The study will include both male and female patients.
All patients presenting with complaints of recent onset of neurological deficiet or
vascular symptoms( weakness of either upper or lower limbs, hemiplegia, TIA, pulsatile neck
swelling), high risk patients( diabetes, hypertension, hyperlipidaemia )
will be taken into
consideration in the study.
The ultrasound examination will include colour Doppler evaluation of the extra cranial
portion of ICA and ECA; CT scan (if required) and MRI scan (if required); Complete
Haemogram; RBS; and urine examination.
9
APPENDIX- I I C
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTEREVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER
ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.
YES
Ultrasonic Examination:
1
Extra cranial carotid artery colour doppler evaluation( common carotid artery,
bifurcation, internal, external carotid arteries) scanned from the supraclavicular notch to
the angle of the jaw.
Investigations:
Other Tests
1
CT scan (if required)
2
MRI ( if required)
3
RBS
4
Complete blood and urine examination
5
Evaluation of hypertension in the patient if any.
6
Evaluation of diabetes mellitus in the patient if any.
10
APPENDIX-II D
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
“ROLE OF COLOUR DOPPLER
SONOGRAPHY IN THE
EVALUATION OF VASCULAR
DISEASES OF THE EXTRA
CRANIAL CAROTID VESSELS”
a Title of the study
Dr. VINAY SAGAR. K
b Principle investigator
(Name and Designation)
PG IN MD RADIODIAGNOSIS
A.I.M.S., B.G.NAGARA.
GUIDE:
Dr. B.V.BALAKRISHNA
PROFESSOR AND HEAD
DEPARTMENT OF RADIODIAGNOSIS
AIMS, B.G.NAGARA -571448.
c Co-investigator
(Name and Designation)
d Name of the Collaborating Department/Institutions
e
Whether permission has been obtained from the heads of
the collaborating departments & Institution
NA
NA
Section - B
Summary of the Project
APPENDIX - II
Section - C
Objectives of the study
APPENDIX - IC
Section - D
Methodology
APPENDIX - IIB
A Where the proposed study will be undertaken
SAH & RC , B.G.NAGARA
B Duration of the project
C Nature of the subjects:
Does the study involve adult patients?
Does the study involve children?
Does the study involve normal volunteers?
Does the study involve Psychiatric patients?
Does the study involve pregnant woman?
2 years
YES
NO
NO
NO
NO
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D If the study involves health volunteers
I. Will they be institute students?
II. Will they be institute employees?
III. Will they be Paid? '
IV. If they are to be paid, how much
Per session?
NO
NO
NO
NO
E
Is the study a part of multi central trial?
NO
F
If yes, who is the coordinator?
(Name and Designation)
NA
Has the trial been approved by the ethics Committee of
the other centers?
NA
If the study involves the use of drugs, please indicate
among the followings :-
NA
I. The drug is marketed in India for the indication in which it
will be used in the study.
NA
II. The drug is marketed in India but not for the
indication in which it will be used in the study
NA
III. The drug is only used for experimental use in humans.
IV. Clearance of the drugs controller of
India has been obtained for:
Use of the drug in healthy volunteers
Use of the drug in-patients for a new
Indication.
Phase one and two clinical trials
Experimental use in-patients and healthy
Volunteers.
G
NA
NA
How do you propose to obtain the drug to be used in the
study?
- Gift from a drug company
- Hospital supplies
- Patients will be asked to purchase
Other sources (Explain)
12
NA
NA
NA
NA
H Funding (If any) for the project please state
- None
- Amount
- Source
- To whom payable
I
NO
Does any agency have a vested interest in the outcome of
the Project?
NO
J Will data relating to subjects /controls be stored
in a computer?
NO
K Will the data analysis be done by
- The researcher?
- The funding agent
YES
NO
L Will technical / nursing help be required form the staff of
hospital.
If yes, will it interfere with their duties?
Will you recruit other staff for the duration of the
study?
If Yes give details of
I.
Designation
II.
Qualification
III. Number
IV.
Duration of Employment
M Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent?
Will it be taken from the subject themselves?
Will it be from the legal guardian? If no, give reason:
N Describe design, Methodology and techniques
YES
NO
NO
NA
YES
NO
YES
YES
YES
APPENDIX - II
Ethical clearance has been accorded
Chairman,
P.G Training cum - Research Institute,
A.I.M.S, B.G.Nagara.
Date:
13
APPENDIX III 8.0
LIST OF REFERENCES
1. Dalan PM. Cerebrovascular disorders. In : Shah SN ed. API textbook of Medicine, 7th ed. Mumbai:
The association of physicians of India. 2003: 796-797.
2. Fontenelle LJ, Simper SC, Hanson TL: carotid duplex scan versus angiography in evaluation of
carotid artery disease. Am Surg 1994; 60:864- 868.
3. Bluth E.I Kay. D Monographic characterization of carotid plaque detection of haemorrhage A.J.R
1986; 146:1061-1065.
4. Bluth E.I, Kay D, merritt CRB, et al : Sonographic characterization of carotid plaque : detection of
haemorrhage. AJNR 1986 ; 7: 311-314.
5. Erickson S.J Middleton W.D Mewissien M.W et al : Stenosis of the internal carotid artery:
Assessment using colour doppler imaging compared with angiography AJR 1989 ; 152: 1299-1305.
6. Jhonson J.M: Angiography and ultrasound in diagnosis of carotid artery disease : a comparision.
Contemp Surg 1981; 70:70-93.
7. Bluth EI, Shyn PB, Sullivan MA, et al: Doppler color flow imaging of carotid artery dissection. J
Ultrasound Med 1989; 8: 149-153.
8. Hennerici M, Steinke W, Rautenberg W: High-resistance Doppler flow pattern in extacranial
carotid dissection. Arch Neurol 1989; 46: 670-672.
14
9. Steinke W, Hennerici M, Aulich A: Doppler colour flow imaging of carotid body tumors. Stroke
1989; 20: 1574-1577.
10. Grant EG, Wong W, Tessler F, et al: Cerebrovascular ultrasound imaging. Radiol Clin North Am
1988; 26 :1111-1130.
11. Bresslau P.J, Fell G, Phillips DJ; et al, Evaluation of carotid bifurcation disease arch. Surgery
1982 117: 58-60.
12. Busuttil R.W., Baker J.d., et al : Carotid artery stenosis Hemodynamic significance and
clinical course. JAMA, 1981; 245, 1438.
13.Carol.B ; Duplex Doppler analysis of carotid bifurcation in patients with documented
hemispheric neurological events J Vase Med 1988; 7: 39-52
14. Carpenter JP Lexa FJ Davis JT et al .'Determination of 60% or greater carotid artery stenosis by
duplex ultrasonography J Vase Surg 1995; 6: 697-703
15. Carrol B.A : Duplex Doppler carotid sonography ,In : Rumack Wilson (eds) Diagnostic
Sonography Principles and Clinical applications Saunders 1999 ; 762-790.
16. Zweibel WJ Doppler evaluation of carotid stenosis in Introduction to vascular sonography IV ed
2000 ; 95 -177
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