| CTRI Number |
CTRI/2022/02/040063 [Registered on: 07/02/2022] Trial Registered Prospectively |
| Last Modified On: |
07/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study of patients with rheumatic heart disease at MMC (Madras Medical College) |
|
Scientific Title of Study
|
MMC Rheumatic Heart Disease Registry |
| Trial Acronym |
M-RHD Registry |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Justin Paul G |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
2nd floor, Institute of Cardiology, Rajiv Gandhi Government General Hospital, Chennai
1st floor, State Program Management Unit,
Institute of Cardiology, Rajiv Gandhi Government General Hospital, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Justin Paul G |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
Second floor,Institute of Cardiology
Rajiv Gandhi Government General Hospital,
Madras Medical College
First floor,State Program Management Unit, Institute of Cardiology
Rajiv Gandhi Government General Hospital,
Madras Medical College
Chennai
TAMIL NADU
600003
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Justin Paul G |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
Second floor,Institute of Cardiology
Rajiv Gandhi Government General Hospital,
Madras Medical College
First floor,State Program Management Unit,
Institute of Cardiology
Rajiv Gandhi Government General Hospital,
Madras Medical College
Chennai
TAMIL NADU
600003
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Madras Medical College |
| Address |
Institute of Cardiology
Madras Medical College
EVR Salai, Park Town, Chennai-600003 |
| Type of Sponsor |
Government 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 G Justin Paul |
Rajiv Gandhi Government General Hospital, Madras Medical College |
Institute of Cardiology,Rajiv Gandhi Government General Hospital,
EVR Salai, Park Town, Chennai-600002
Chennai
TAMIL NADU |
91-9840071558
drjpheart@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I019||Acute rheumatic heart disease, unspecified, (2) ICD-10 Condition: I099||Rheumatic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. All consecutive patients diagnosed to have definite RHD using standard clinical and echocardiographic criteria, seen at outpatient facilities, emergency departments, or inpatient facilities of the participating hospitals irrespective of their age and other comorbidities during the study period are eligible for inclusion in the study.
2. Inpatients will be eligible if RHD is the reason for their admission to hospital. This will include conditions directly attributable to RHD, such as, heart failure, cardiac arrhythmia, and stroke.
|
|
| ExclusionCriteria |
| Details |
1. Patients with primary diagnosis of valvular disease other than RHD (eg, degenerative disease)
2. Patients with borderline criteria for RHD
3. No informed consent/assent.
4. Patients without evidence of echocardiography ascertained valvular disease were excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mortality
Cardiac Hospitalisation |
One year Three year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Surgery of Intervention
Other Complication |
One year Three year |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
08/02/2022 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drjpheart@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Literature of the profile, pattern and intermediate term outcome of patients with Rheumatic Heart Disease from South India in the recent era, is scarce. This registry seeks to collect information regarding the same. All patients seeking care in our institution with rheumatic heart disease will be enrolled and followed up for three years.
|