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CTRI Number  CTRI/2024/05/066818 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Significance of small bleeds in brain MRI scan and their relation to patients symptoms 
Scientific Title of Study   Topographical patterns of cerebral microbleeds in acute ischemic stroke subtypes and its association with cognition and risk factors of stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dandapantula Sushrutha 
Designation  Neurology Registrar 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Neurology, Room number 11, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  9246896096  
Fax    
Email  sushruthamahidhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  sripadma pv 
Designation  assistant professor in department of neurology 
Affiliation  kasturba medical college 
Address  department of neurology room number 12 neurology division kasturba medical college maniapl udupi karnataka

Udupi
KARNATAKA
576104
India 
Phone  9901422624  
Fax    
Email  sripadma.pv@manipal.edu  
 
Details of Contact Person
Public Query  
Name  sripadma pv 
Designation  assistant professor in department of neurology 
Affiliation  kasturba medical college 
Address  department of neurology room number 12 neurology division kasturba medical college maniapl udupi karnataka

Udupi
KARNATAKA
576104
India 
Phone  9901422624  
Fax    
Email  sripadma.pv@manipal.edu  
 
Source of Monetary or Material Support  
Department of Neurology, Room no 11, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka, India, Pincode 576104 
 
Primary Sponsor  
Name  dandapantula sushrutha 
Address  Department of Neurology, Room no 11, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka, India, Pincode 576104 
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 Dandapantula Sushrutha  Kasturba Medical College and Hospital attached to Kasturba Medical College  Department of Neurology, Room no 11, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka, India, Pincode 576104
Udupi
KARNATAKA 		 9246896096

sushruthamahidhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G46||Vascular syndromes of brain in cerebrovascular diseases, (2) ICD-10 Condition: G45||Transient cerebral ischemic attacks and related syndromes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adults more than 18 years of age presenting with acute ischemic stroke of less than 24 hours duration 
 
ExclusionCriteria 
Details  Patients with neoplasms, intracranial surgery, traumatic brain injury, thrombocytopenia, bleeding diathesis, venous hemorrhagic infarcts and metallic implants insitu which is contraindication for MRI brain 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Determine the prevalence and topographic patterns of cerebral microbleeds in subtypes of acute ischemic stroke
To compare the vascular risk factors, white matter lesion load, prior antiplatelet or anticoagulant use in patients with and without cerebral microbleeds
Evaluate the scores of MoCA in patients of acute ischemic stroke with and without cerebral microbleeds 		 To Determine the prevalence and topographic patterns of cerebral microbleeds in subtypes of acute ischemic stroke at the index admission within 24 hours
To compare the vascular risk factors, white matter lesion load, prior antiplatelet or anticoagulant use in patients with and without cerebral microbleeds at the index admission within 24 hours
Evaluate the scores of MoCA in patients of acute ischemic stroke with and without cerebral microbleeds at the index admission within 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the presence of hemorrhagic transformation after thrombolysis in patients with & without cerebral microbleeds  To evaluate the presence of hemorrhagic transformation after thrombolysis in patients with & without cerebral microbleeds within 24 hours of thrombolysis 
 
Target Sample Size   Total Sample Size="319"
Sample Size from India="319" 
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)   24/05/2024 
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   The study will be conducted in the Department of Neurology Kasturba Medical College and Kasturba Hospital, Manipal. Patients who fulfill the inclusion criteria mentioned above will be approached. Eligible patients will be explained in detail about the study in their best understandable language and given a participant information sheet. Informed consent will be taken from participants who are willing to participate in the study after fully understanding the nature of the study and its risks/benefits. For patients who present with acute ischemic stroke General physical examination and detailed neurological examination will be conducted. Stroke severity will be assessed by NIHSS and stroke classified as per TOAST classification. Montreal Cognitive Assessment Score will be employed to assess cognitive status. Necessary blood investigations in consenting patients will be sent. MRI imaging of the patients will be accessed and the Cerebral microbleeds will be evaluated and quantified. A standard data collection proforma is designed to collect the above-mentioned information on demographic profiles, other associated symptoms, risk factors, and general and systemic examinations. All the proformas employed for testing are freely available. There will be no risk in the study as no additional tests are performed and only standard-of-care tests and procedures will be followed. Parameters recorded in the study are part of routine clinical care of the acute ischemic stroke protocol. 
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