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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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