| CTRI Number |
CTRI/2019/03/018327 [Registered on: 29/03/2019] Trial Registered Prospectively |
| Last Modified On: |
24/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of stroke in individuals less than 45 years of age |
|
Scientific Title of Study
|
A study of stroke in individuals less than 45 years of age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kollipara Sumanth |
| Designation |
Junior Resident |
| Affiliation |
Kasturba hospital, Manipal |
| Address |
Department of General Medicine, Kasturba hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drsumanth25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B A Shastry |
| Designation |
Professor |
| Affiliation |
Kasturba hospital, Manipal |
| Address |
Department of General Medicine, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
ba.shastry@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kollipara Sumanth |
| Designation |
Junior Resident |
| Affiliation |
Kasturba hospital, Manipal |
| Address |
Department of General Medicine, Kasturba hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drsumanth25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, Kasturba hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba hospital Manipal |
| Address |
Department of General Medicine, Kasturba hospital, Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 K Sumanth |
Kasturba hospital, Manipal |
Department of General Medicine, Kasturba hospital, Manipal
Udupi
KARNATAKA |
9494476531
drsumanth25@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All patients of 18- 45 years of age of both sexes who give informed consent,
Proven cases of Stroke by the following criteria- stroke causing measurable neurological deficit by means of History, Physical Examination and Imaging |
|
| ExclusionCriteria |
| Details |
strokes because of neuroendovascular procedures or coronary angiography,
Blood glucose concentration <50 mg/dl (2.7mmol/L),
Transient Ischemic attack,
Seizures,
Syncope,
Migraine,
Metabolic encephalopathy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Stroke in individuals less than 45 years of age would be
significant
Hypertension, smoking, cardiac disease and dyslipidemia will emerge as important risk factors |
DAY 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevalence of Stroke in individuals less than 45 years of age would be
significant
Hypertension, smoking, cardiac disease and dyslipidemia will emerge as important risk factors |
DAY 1 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
03/04/2019 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is to assess Risk factors, etiology and clinical features of stroke in the individuals age group of less than 45 years. The incidence of Stroke in Young individuals in India is showing a marked upward trend and this study may contribute towards an increased understanding of which could facilitate management of such patients in the future. The primary outcome being Prevalence of Stroke in individuals less than 45 years of age would be significant and Hypertension, smoking, cardiac disease and dyslipidemia will emerge as important risk factors |