| CTRI Number |
CTRI/2019/12/022379 [Registered on: 13/12/2019] Trial Registered Prospectively |
| Last Modified On: |
12/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to evaluate outcomes of Percutaneous Coronary Intervention of patients with ST elevation MI over 1 year. |
|
Scientific Title of Study
|
A PRospective Observational study to evaluate Percutaneous coronary Intervention Outcomes of patients with ST-Elevation MI over 1 year at tertiary care center. (PROPOSE) |
| Trial Acronym |
PROPOSE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1 dated 1 March 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chirag Sheth |
| Designation |
Interventional Cardiologist |
| Affiliation |
Rhythm Heart Institute |
| Address |
Near Siddharth Bunglows,
Sama Savli Road
Vadodara
GUJARAT
390022
India |
| Phone |
02652541006 |
| Fax |
02652541006 |
| Email |
drcvs_73@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Sheth |
| Designation |
Interventional Cardiologist |
| Affiliation |
Rhythm Heart Institute |
| Address |
Near Siddharth Bunglows,
Sama Savli Road
Vadodara
GUJARAT
390022
India |
| Phone |
02652541006 |
| Fax |
02652541006 |
| Email |
drcvs_73@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Megha Patel |
| Designation |
Head- Clinical Research |
| Affiliation |
Rhythm Heart Institute |
| Address |
Near Siddharth Bunglows
Sama Savli Road
Vadodara
GUJARAT
390022
India |
| Phone |
02652541006 |
| Fax |
02652541006 |
| Email |
pmeghacr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Chirag Sheth
Rhythm Heart Institute
Near Siddharth Bunglows,
Sama-Savli Road,
Vadodara-22 |
|
|
Primary Sponsor
|
| Name |
Dr Chirag Sheth |
| Address |
Rhythm Heart Institute
Near Siddahrth Bunglows
Sama-Savli Road,
Vadodara-22
Gujarat |
| Type of Sponsor |
Other [Self] |
|
|
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 Chirag Sheth |
Rhythm Heart Istitute |
Near Siddharth Bunglows,
Sama-Savli Road
Vadodara
Vadodara
GUJARAT |
02652541006
02652541006
drcvs_73@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rhythm Heart Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing Percutaneous coronary Intervention with ST elevation Myocardial Infraction present within 7 days of index event. |
|
| ExclusionCriteria |
| Details |
1. Age less than or equal to 18 years
2. Patient undergoing Coronary Artery Bypass Surgery.
3. Patients with ST Elevation Myocardial Infarction not undergoing Pecutaneous interaction either due to co-morbid condition or anatomy not suitable for PCI.
4. Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Composite of all cause death, myocardial infarction, ischemia driven revascularization, hospitalization for heart failure. |
Timepoints are as described below:
1] 7th day of discharge
2] At 1 month
3] At 3 months
4] At 6 months
5] At 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Cardiac death
2.Hospitalization for acute coronary syndrome
3.Hospitalization for heart failure
4.Definite stent thrombosis
5.Ischemia driven revascularization |
1 year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
16/12/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS OBSERVATIONAL STUDY IS BEING CONDUCTED TO EVALUATE THE EARLY AND LATE OUTCOMES OF PERCUTANEOUS CORONARY ANGIOPLASTY AFTER ST ELEVATION MYOCARDIAL INFARCTION AT A TERTIARY CARE CENTRE IN INDIA. THE LONG TERM DATA OF PRIMARY PCI, EARLY PHARMACOINVASIVE APPROACH AND RESCUE PCI IS SPARSE IN INDIA. SO THIS OBSERVATIONAL STUDY IS IMPORTANT TO EVALUATE THE OUTCOME OF SUCH PATIENTS IN INDIAN SCENARIO. |