| CTRI Number |
CTRI/2024/07/070167 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Outcomes of Primary Percutaneous Coronary Intervention in Young Diabetic vs Non-Diabetic patients |
|
Scientific Title of Study
|
Comparative outcomes of Primary Percutaneous Coronary Intervention in Young Diabetic vs Non-Diabetic Acute Myocardial Infarction patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonu Kumar Pandit |
| Designation |
DM Senior Resident |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Cardiology,
VMMC and Safdarjung Hospital, New
Delhi
Department of Cardiology, SSB building, Safdarjung Hospital, New
Delhi
South
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9953043951 |
| Fax |
|
| Email |
dr.sonupandit.gsvm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H S Isser |
| Designation |
Professor and HOD |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Cardiology, SSB building, VMMC and Safdarjung Hospital, New
Delhi
Department of Cardiology, SSB building, Safdarjung Hospital, New
Delhi
South
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9899128399 |
| Fax |
|
| Email |
drhsisser@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonu Kumar Pandit |
| Designation |
DM Senior Resident |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Cardiology, SSB building, Safdarjung Hospital, New
Delhi
Department of Cardiology, SSB building, Safdarjung Hospital, New
Delhi
South
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9953043951 |
| Fax |
|
| Email |
dr.sonupandit.gsvm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of Department of Cardiology; SSB Building;
VMMC and Safdarjung Hospital,
New Delhi; India. PIN- 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung hospital |
| Address |
VMMC and Safdarjung hospital, Mahatma Gandhi Marg, Ansari
Nagar West, New Delhi, 110029 |
| 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 |
| DrSonu Kumar Pandit |
VMMC and Safdarjung Hospital, New Delhi |
VMMC and Safdarjung
Hospital, Mahatma
Gandhi Marg, Ansari
Nagar West, New
Delhi- 110029
South
DELHI
South
DELHI |
9953043951
dr.sonupandit.gsvm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee, VMMC and Safdarjung Hospital |
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
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Acute Myocardial Infarction patients undergoing Primary Percutaneous Coronary Intervention in Males of age upto 45 years and Females upto age 55 years. |
|
| ExclusionCriteria |
| Details |
1- Allergy to contrast material
2- Left Main lesion
3- Cardiogenic shock or Hemodynamic unstability
4- When dual anti-platelet therapy (DAPT) was contraindicated |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare in-hospital and 6th month MACE (Major Adverse Cardiovascular Events) in young diabetic vs non-diabetic acute myocardial infarction patients |
In-hospital and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- To compare in-hospital and 6th month outcomes of individual components of primary objective; i.e., Death, Re-infarction, Target vessel revascularization and Heart failure hospitalization.
2- To compare; ST-segment resolution at 60 minutes post PCI; Post PCI TIMI flow, Slow flow/No flow and Improvement of Ejection Fraction at Discharge and at 6th month. |
In-hospital and at 6th month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a prospective cohort trial to study the comparative outcomes of primary percutaneous coronary intervention in young diabetic vs non-diabetic acute myocardial infarction patients. This study will be conducted
in Department of Cardiology, VMMC and Safdarjung Hospital, New Delhi. 80 patients undergoing Primary PCI and meeting inclusion criteria will be included. The patients will be followed up after a period of 6
months. Primary and secondary outcomes will be assessed in-hospital and at 6th month follow-up. |