| CTRI Number |
CTRI/2012/05/002635 [Registered on: 09/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
08/05/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk factor survey among cerebral stroke patients admitted in hospital |
|
Scientific Title of Study
|
In Hospital Prospective Stroke Registry-Risk Factor Survey |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 001 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Bhattacharjee |
| Designation |
Research Scientist |
| Affiliation |
LKMM Turst Research Centre at Lilavati Hospital |
| Address |
LKMM Trust Research Centre
At Lilavati Hospital
A-791, Bandra Reclamation
Mumbai
Mumbai
MAHARASHTRA
400050
India |
| Phone |
912226568000 |
| Fax |
912226406844 |
| Email |
mitabh34@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Bhattacharjee |
| Designation |
Research Scientist |
| Affiliation |
LKMM Turst Research Centre at Lilavati Hospital |
| Address |
LKMM Trust Research Centre
At Lilavati Hospital
A-791, Bandra Reclamation
Mumbai
Mumbai
MAHARASHTRA
400050
India |
| Phone |
912226568000 |
| Fax |
912226406844 |
| Email |
mitabh34@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Bhattacharjee |
| Designation |
Research Scientist |
| Affiliation |
LKMM Turst Research Centre at Lilavati Hospital |
| Address |
LKMM Trust Research Centre
At Lilavati Hospital
A-791, Bandra Reclamation
Mumbai
Mumbai
MAHARASHTRA
400050
India |
| Phone |
912226568000 |
| Fax |
912226406844 |
| Email |
mitabh34@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Lilavati Hospital
A-791, Bandra Reclamation
Mumbai 400050 |
|
|
Primary Sponsor
|
| Name |
LKMM Trust Research Centre |
| Address |
LKMM Trust Research Centre
At Lilavati Hospital
A-791, Bandra Reclamation
Mumbai 400050 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 M Bhattacharjee |
Lilavati Hospital |
Research Department,A-791, Bandra Reclamation
Mumbai 400050
Mumbai (Suburban)
MAHARASHTRA |
912226568000
912226406844
mitabh34@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LKMM Trust Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Risk factors in stroke(CVA) patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
all first ever stroke patients and recurrant stroke patients admitted in Lilavati hospital |
|
| ExclusionCriteria |
| Details |
age below 20 years and TIA |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| risk factor analysis, morbidity and mortality outcome by Modified Rankin scale and Barthel Index |
at 28 days, 3 months, 6 months and 1 year post stroke |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
20/04/2012 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. Rapid urbanization and changing lifestyle patterns have led to rising behavioral and biological risk factor levels in the population. Published reports also suggest that CVD occurs at all ages in both sexes with increasing frequency with advancing age. The first step to understand the burden of stroke in India, is to assess the current risk factor profile. The distribution of risk factors among the population is the key information required by countries in their planning of prevention and control programmes. |