| CTRI Number |
CTRI/2024/03/064006 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of magnetic resonance angiography(MRA) in cerebral ischemic patients with carotid artery stenosis and its correlation with carotid doppler |
|
Scientific Title of Study
|
Comparison of magnetic resonance angiography(MRA) as diagnostic tool for carotid artery stenosis with carotid doppler in cerebral ischemic patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUSTAFA ALI KHAN MOHAMMED |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
DY PATIL MEDICAL COLLEGE HOSPITAL |
| Address |
D Y PATIL HOSPITAL, DEPARTMENT OF RADIO-DIAGNOSIS, SONAL COLONY, SCHEME NO.4, LAXMINARAYAN NAGAR, KADAMWADI, KOLHAPUR D Y PATIL HOSPITAL, DEPARTMENT OF RADIO-DIAGNOSIS, SONAL COLONY, SCHEME NO.4, LAXMINARAYAN NAGAR, KADAMWADI, KOLHAPUR MAHARASHTRA 416003 Kolhapur MAHARASHTRA 416003 India |
| Phone |
9393520369 |
| Fax |
|
| Email |
arif2mdkhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MUSTAFA ALI KHAN MOHAMMED |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
DY PATIL MEDICAL COLLEGE HOSPITAL |
| Address |
D Y PATIL HOSPITAL, DEPARTMENT OF RADIO-DIAGNOSIS, SONAL COLONY, SCHEME NO.4, LAXMINARAYAN NAGAR, KADAMWADI, KOLHAPUR D Y PATIL HOSPITAL, DEPARTMENT OF RADIO-DIAGNOSIS, SONAL COLONY, SCHEME NO.4, LAXMINARAYAN NAGAR, KADAMWADI, KOLHAPUR Kolhapur MAHARASHTRA 416003 India |
| Phone |
9393520369 |
| Fax |
|
| Email |
arif2mdkhan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
MUSTAFA ALI KHAN MOHAMMED |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
DY PATIL MEDICAL COLLEGE HOSPITAL |
| Address |
D Y PATIL HOSPITAL, DEPARTMENT OF RADIO-DIAGNOSIS, SONAL COLONY, SCHEME NO.4, LAXMINARAYAN NAGAR, KADAMWADI, KOLHAPUR D Y PATIL HOSPITAL, DEPARTMENT OF RADIO-DIAGNOSIS, SONAL COLONY, SCHEME NO.4, LAXMINARAYAN NAGAR, KADAMWADI, KOLHAPUR Kolhapur MAHARASHTRA 416003 India |
| Phone |
9393520369 |
| Fax |
|
| Email |
arif2mdkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. Y. PATIL MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
MUSTAFA ALI KHAN MOHAMMED |
| Address |
D Y PATIL HOSPITAL, DEPARTMENT OF RADIO-DIAGNOSIS, SONAL COLONY, SCHEME NO.4, LAXMINARAYAN NAGAR, KADAMWADI, KOLHAPUR |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr NIRANJAN BAPUSAHEB PATIL |
DY PATIL MEDICAL COLLEGE HOSPITAL |
DEPARTMENT OF RADIO-DIAGNOSIS, SONAL COLONY, SCHEME NO.4, LAXMINARAYAN NAGAR Kolhapur MAHARASHTRA |
9422045384
nbpatil10@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, D. Y. PATIL MEDICAL COLLEGE, KOLHAPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I708||Atherosclerosis of other arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients clinically diagnosed of cerebral infarct.
Patients referred to the department of radiodiagnosis with MRA or carotid doppler requisition on advice of a referring doctor.
|
|
| ExclusionCriteria |
| Details |
Patients with previous history of endarterectomy surgery.
Patients with cardiac pacemakers, ferromagnetic aneurysm clips, cochlear implants and other ferromagnetic implants.
Patients with claustrophobia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Carotid artery stenosis in acute ischemic stroke patients |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="49" Sample Size from India="49"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Stroke is defined as rapid onset of focal neurological deficit resulting from
diseases of cerebral vasculature and its contents. Carotid artery stenosis is a common condition
encountered in general practice. It represents one of the major causes of
acute ischemic stroke. Carotid artery stenosis can be classified as
symptomatic or asymptomatic disease with the distinction between the two
significantly altering the management pathway.
- Community surveys in India have shown a
crude prevalence rate
for hemiplegia in
the range of
200 per 100,000
persons, nearly 1.5% of all urban hospital admission, 4.5% of all medical and around 20% of neurological cases.
- Stroke
is one of the leading causes of mortality and morbidity. Ischemic infarcts account for 80-85% of all strokes. Stroke related
neurological disability has a
major impact on the patient, family members and caretakers. 17% will remain institutionalized and 25-30%
will need moderate to total assistance for activities of
daily living.
- Carotid
atherosclerosis is one of the main risk factor for ischemic stroke which accounts for 5-10% of all
ischemic stroke. The
widely used TOAST (Trial of Org 10172 in Acute Stroke Treatment)
classification of ischemic stroke distinguishes
5 major categories of stroke : Large artery atherosclerosis, Cardioembolism,
Small vessel occlusion, Other determined etiology and Undetermined etiology. Carotid plague progression contributes to
increasing stroke risk.
- Carotid endarterectomy has been shown to effectively reduce the
risk of developing stroke in patients with significant stenosis i.e.
70% or more.
- Various
noninvasive vascular techniques can now be used to evaluate Carotid atherosclerosis which includes Carotid Doppler Ultrasonography,
transcranial Doppler, CT
angiography, Magnetic Resonance angiography,
contrast enhanced
Magnetic Resonance angiography.
- Among the tests Carotid
Doppler ultrasound is a noninvasive, cost effective and
easy available mode of investigation to identify the patients with significant stenosis and other changes due to atherosclerosis.
- Since the noninvasive tests are used
for preliminary screening before doing Carotid
endarterectomy the value of the tests lie in their ability to accurately
identify patients with significant stenosis. However newer studies of older technologies and the emergence
of new noninvasive tests justify
a revaluation of published data about noninvasive testing of Carotid arteries.
- The purpose of this study is to estimate retrospectively the various changes in Carotid arteries by Magnetic resonance
angiography in patients who had already
suffered a stroke, which in turn determine the value of using Magnetic
resonance angiography as a modality of test to screen for atherosclerosis
and the risk of developing stroke in people with risk factors for stroke.
|