| CTRI Number |
CTRI/2023/04/051635 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing heart scan criterias in patients with unknown cause of stroke and normal patients |
|
Scientific Title of Study
|
Comparison of LA functional parameters by echocardiography between cryptogenic stroke patients and healthy controls |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Febina Sherin |
| Designation |
Student |
| Affiliation |
MAHE |
| Address |
Room No.212,IInd floor Department of Cardiovascular Technology
MAHE
Manipal
Udupi
Karnataka
INDIA
Udupi
KARNATAKA
576104
India |
| Phone |
7558934968 |
| Fax |
|
| Email |
febinasherin51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnananda Nayak |
| Designation |
HOD & Associate Professor |
| Affiliation |
MAHE |
| Address |
Room No.212,IInd floor Department of Cardiovascular Technology
MAHE
Manipal
Udupi
Karnataka
INDIA
Udupi
KARNATAKA
576104
India |
| Phone |
9964015487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnananda Nayak |
| Designation |
HOD & Associate Professor |
| Affiliation |
MAHE |
| Address |
Room No.212,IInd floor Department of Cardiovascular Technology
MAHE
Manipal
Udupi
Karnataka
INDIA
Udupi
KARNATAKA
576104
India |
| Phone |
9964015487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology ,Kasturba Medical College and Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Deparment of Cardiology |
| Address |
Kasturba Medical College and Hospital, MAHE, Manipal |
| 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 |
| Febina Sherin |
Kasturba Hospital |
Room No:34, 3rd Floor OPD block, Manipal
Udupi
KARNATAKA |
7558934968
febinasherin51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Hospital ,Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I30-I52||Other forms of heart disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Cases:
Cryptogenic stroke Patients with no pre-existent cardiovascular disease and who are age less than 50 years.
Controls:
Normotensive individuals from age and gender-matched groups are referred for echocardiography and are recruited for the study.
|
|
| ExclusionCriteria |
| Details |
for case and controls
Arrhythmias ( Any history of AF or atrial flutter)
Pregnancy
Valvular Heart Disease(VHD)
Coronary Artery Disease(CAD)
Congenital Heart Disease(CHD)
Known or suspected cardiomyopathy
Lacunar infarct with HTN
Large artery infarct – Diagnosed by CT/MRI scan and CV Doppler
Patients who are not willing to give consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the spectrum of LA strain parameters in patients with cryptogenic stroke.
To evaluate atrial anatomy and function using LA strain.
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate differences in LA function by LA strain between patient with cryptogenic stroke and controls.
Assessing the Left atrial appendage anatomy in cryptogenic stroke patients.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2023 |
| Date of Study Completion (India) |
15/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Speckle tracking echocardiography is an extremely useful technique to improve the diagnosis of atrial disease and function in cryptogenic stroke and it could be a great assistance in stratifying the thromboembolic risk. 1. Primary objective: To study the spectrum of LA strain parameters in patients with cryptogenic stroke and to evaluate atrial anatomy and function using LA strain 2. Secondary objective: To evaluate differences in LA function by LA strain between patients with cryptogenic stroke and controls and Assessing the left atrial appendage anatomy in cryptogenic stroke patients |