| CTRI Number |
CTRI/2022/02/040002 [Registered on: 03/02/2022] Trial Registered Prospectively |
| Last Modified On: |
03/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Revascularisation Delay in Heart Attack Study |
|
Scientific Title of Study
|
Revascularisation Delay in ST Elevation Myocardial Infarction (STEMI) Study |
| Trial Acronym |
RD-STEMI Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Justin Paul |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
First Floor, Institute of Cardiology, Rajiv Gandhi Government General Hospital, Chennai-600085
Chennai
TAMIL NADU
600002
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Justin Paul |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
First Floor, Institute of Cardiology, Rajiv Gandhi Government General Hospital, Chennai-600085
TAMIL NADU
600002
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Justin Paul |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
First Floor, Institute of Cardiology, Rajiv Gandhi Government General Hospital, Chennai-600085
TAMIL NADU
600002
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras Medical College, Chennai |
|
|
Primary Sponsor
|
| Name |
Madras Medical College |
| Address |
Rajiv Gandhi Government General Hospital
EVR Salai, Park Town, Chennai-600002 |
| 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 |
RD STEMI Study |
First Floor, State Program Management Unit,
Rajiv Gandhi Government General Hospital, 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: I213||ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients with Acute STEMI seeking care at our Institution will be eligible for inclusion |
|
| ExclusionCriteria |
| Details |
Not willing participants
STEMI patients seeking care at our institution as teh first point of medical contact |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
in hospital and one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Revascularisation delay
2. No of hospitals visited enroute to our instituion
3. Reasons for not recieving revascularisation at the various points of contact |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
07/02/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
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
Response - Clinical Study Report
- 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 01-12-2022 and end date provided 31-12-2025?
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
|
Patients with STEMI often do not receive timely reperfusion. This is more common in Low-and middle-income countries.
This happens despite patients reaching revascularisation capable hospitals within the time window.
This observational study aims at identifying the possible reasons behind the reasons for patients getting no or delayed revascularisation in STEMI.
|