| CTRI Number |
CTRI/2025/04/085985 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Using 3D heart scans to compare how the heart works in Indian stroke patients with no known cause and in healthy individuals. |
|
Scientific Title of Study
|
Comparison of LA function in cryptogenic stroke patients and healthy controls using 3D Echocardiography: A case and control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Hegde |
| Designation |
Postgraduate student |
| Affiliation |
Manipal college of health profession |
| Address |
Room No. 202, 2nd floor, Department of Cardiovascular Technology, Manipal college of health profession, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535467321 |
| Fax |
|
| Email |
shivanihedge2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Sridevi Prabhu |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal college of health profession |
| Address |
Room No. 202, 2nd floor, Department of Cardiovascular Technology, Manipal college of health profession, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867902764 |
| Fax |
|
| Email |
sridevi.santhosh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sridevi Prabhu |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal college of health profession |
| Address |
Room No. 202, 2nd floor, Department of Cardiovascular Technology, Manipal college of health profession, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867902764 |
| Fax |
|
| Email |
sridevi.santhosh@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal academy of higher education |
| Address |
Manipal academy of higher education, Manipal, Udupi, Karnataka, India, 576104 |
| 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 Krishnananda Nayak |
Kasturba Hospital Manipal |
Echo room, Department of neurology, Kasturba medical college and hospital, Manipal academy of higher education, Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
9964015487
krishnananda.n@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases: Cryptogenic stroke patients with no history of more than Mild VHD, CAD, CHD
Age less than 50years
2. Controlled individuals: Normotensive individuals, age and gender matched group who are referred for echocardiography
|
|
| ExclusionCriteria |
| Details |
1. Arrhythmias (Any history of AF or atrial flutter) – diagnosed by ECG or 3-day Holter monitoring
2. Pregnancy
3. Valvular Heart Disease (VHD)
4. Coronary Artery Disease (CAD)
5. Congenital Heart Disease (CHD)
6. Known or suspected cardiomyopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare LA strain and volume by 3D echocardiography in cryptogenic stroke patients and age-gender matched normal individuals
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of LA appendage morphology between two groups |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
15/05/2025 |
| 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) |
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
|
Aim: To compare Left atrial (LA) function in cryptogenic stroke patients and healthy controls using 3D echocardiography.
Justification for study: Previous studies didn’t include three LA strain parameters and LA volume in the assessment of LA function by more accurate 3D echocardiography in cryptogenic stroke patients. Identifying subclinical LA dysfunction by LA strain parameters in 3D echocardiography, provides more insights into underlying mechanisms in cryptogenic stroke patients. This study helps to understand the LA dynamics in Cryptogenic stroke patients and in risk stratification of Cryptogenic stroke patients.
Detailed description of procedure / processes:
After IRC (Institutional research committee), IEC (Institutional ethics committee) approval and CTRI registration (Clinical Trials Registry- India). Cryptogenic stroke patients and age and gender match normal individuals referred for echocardiography will be taken for the study. Test details are explained to the subject and consent will be taken and 12 Lead ECG will be obtained. Echocardiographic parameters will be recorded and analyzed in offline LA strain. Needed 2D echocardiography standard views (A4C, A2C) will be scanned and stored by an experienced cardiac sonographer. Mitral PW doppler and tissue doppler velocities at septal and lateral walls will be recorded. And Conventional echo parameters like LA volume, LA dimension, LA EF, and LA strain will be obtained.
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