| CTRI Number |
CTRI/2017/10/010305 [Registered on: 31/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Exploratory |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Paralysis |
|
Scientific Title of Study
|
A Prospective Observational Exploratory Investigator Initiated Study to Evaluate the Risk Factors for Acute Stroke - A multicentric study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Kumar |
| Designation |
Senior Consultant Neurologist |
| Affiliation |
Apollo Health City |
| Address |
Apollo Health City
Jubilee Hills
Hyderabad
Hyderabad
ANDHRA PRADESH
500096
India |
| Phone |
914023607777 |
| Fax |
|
| Email |
drsudhirkumar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Kumar |
| Designation |
Senior Consultant Neurologist |
| Affiliation |
Apollo Health City |
| Address |
Apollo Health City
Jubilee Hills
Hyderabad
Hyderabad
ANDHRA PRADESH
500096
India |
| Phone |
914023607777 |
| Fax |
|
| Email |
drsudhirkumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Kumar |
| Designation |
Senior Consultant Neurologist |
| Affiliation |
Apollo Health City |
| Address |
Apollo Health City
Jubilee Hills
Hyderabad
Hyderabad
ANDHRA PRADESH
500096
India |
| Phone |
914023607777 |
| Fax |
|
| Email |
drsudhirkumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Current Medical Concepts Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Current Medical Concepts Pvt Ltd |
| Address |
401 Lumbini Lakeview Apts 6 3 1239 27 Raj Bhavan Road
Somajiguda Hyderabad 500082 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Kumar |
Apollo Health City |
Department of Neurology
Apollo Heathcity
Jubilee Hills
Hyderabad 500096
Hyderabad
ANDHRA PRADESH |
9866193953
drsudhirkumar@yahoo.com |
| Dr Antaryami Nanda |
Apollo Hospitals |
Plot No 251
Sainik School road
Unit 15
Bhubaneswar 751 005
Khordha
ORISSA |
8093060239
drantaryami_n@apollohospitals.com |
| Dr Arul Selvan |
Apollo Hospitals |
Department of Neurology
Apollo Hospitals
21 Greams Lane
Off Greams Road
Chennai
Chennai
TAMIL NADU |
914428294735
drarul_s@apollohospitals.com |
| Dr Rakesh Jadhav |
Apollo Hospitals |
Banargetta Road,
Bangalore
Bangalore
KARNATAKA |
919743069363
drrakeshjadav@gmail.com |
| Dr Mukesh Sharma |
Apollo Hospitals International Limited |
Department of Neurology
Apollo Hospitals International Limited
2nd Floor Plot 1A Bhat GIDC Estate Gandhinagar 382428
Gandhinagar
GUJARAT |
9375488882
drmukeshneuro@reddifmail.com |
| Dr Meenakshi Sundaram |
Apollo Specialty Hospital |
Apollo Specialty Hospital
Lake View Road
KK nagar Madurai 625 020
Madurai
TAMIL NADU |
9842980211
drsundarsms@gmail.com |
| Dr Pushpendra Nath Renjen |
Indraprastha Apollo Hospitals |
Department of Neurology
INdraprastha Apollo
SaritaVihar Delhi Mathura Road New Delhi 110076
New Delhi
DELHI |
9810059614
pnrenjen@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Both ischemic and hemorrhagic stroke subjects within 24 hours of onset of symptoms and defined time of onset |
|
| ExclusionCriteria |
| Details |
Subject/LAR refuses to give consent
Subjects who are pregnant |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Correlation of the symptoms with current NIH classification
Correlation of the risk factors with American Stroke Association guideline |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gender based risk factors correlation with the pathological conditions
New symptons correlation with the defined risk factors or new risk factors |
7 days |
|
|
Target Sample Size
|
Total Sample Size="526"
Sample Size from India="526"
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)
|
28/02/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Analysis has shown that improved socioeconomic status and higher education raise awareness of the warning symptoms of stroke for both rural and urban subjects. With varying risk factors responsible for the occurrence of stroke, it becomes mandatory to study the basic genes responsible for stroke in adults and in children also, which may throw light on the therapy and possibly a shift to the treatment mode. Hence the need to know more about the risk factors apart from the defined criteria has to be evaluated to aid in faster diagnosis and proper treatment or any change in the current algorithm. Apollo Hospitals Enterprise Limited, the leading healthcare chain with over 62 hospitals to its network is a pioneer in providing excellent medical care to the patients and considered to take this heart burning problem for conduct of an observational study to evaluate the risk factors of ischemic hemorrhagic stroke in patients admitted in various Apollo Hospital centers.
|