Department of Cardiology, Heart and Soul Super Speciality Hospital, First floor Gangangiri complex Ekatmata Chowk, Camp, Malegaon, Maharashtra 423105 Nashik MAHARASHTRA
8106451300
hdesle@yahoo.com
Dr Jayagopal Pathiyil Balagopal
Lakshmi Hospital
Lakshmi Hospital
Department of Cardiology, Chittur Road, Palakkad, Kerala-678 013
Palakkad KERALA
98470 23777
lakshmihospitallh@gmail.com
Dr Rony Mathew
Lisie Hospital
Lisie Hospital
Department of Cardiology, St. Antony’s Block, Kochi, Kerala- 682018
Ernakulam KERALA
9846097812
drronymathew@yahoo.com
Dr Prashant Pawar
Nidaan Heartcare Clinic, Nashik
Department of Cardiology, Nidaan Heartcare Clinic, Ahilyadevi Holkar Rd, Mumbai Naka, Matoshree Nagar, Nashik, Maharashtra 422002 Nashik MAHARASHTRA
8806329495
prashantpawar125@gmail.com
Dr Sachin Narendra Patil
Sachin Multispeciality Hospital, Klhapur
Department of Cardiology, Sachin Multispeciality Hospital,2nd floor, M6VR+RWJ Sachin superspeciality clinic, The icon building, 6th Ln, near Sarada Medical, Poorvaganga, Mahalaxminagar, Rajarampuri, Kolhapur, Maharashtra 416008 Kolhapur MAHARASHTRA
9225068519
drsachinpatil12@gmail.com
Dr Niteen Vijay Deshpande
Spandan Heart Institute and Research Centre
Department of Cardiology, Spandan Heart Institute and Research Centre, 31, Off Chitale Marg Behind Hitavada Press Dhantoli Nagpur 440012 Nagpur MAHARASHTRA
9823056722
nvdesh@hotmail.com
Dr Prashant Jagtap
Viveka Hospitals, Nagpur
Department of Cardiology, Viveka Hospitals, Plot No. 1A, Naik Layout, Parsodi, Subhash Nagar, Nagpur, Maharashtra 440022 Nagpur MAHARASHTRA
• Presenting with acute coronary syndrome (ACS) specifically STEMI and STEMI equivalents either directly at the institute or referred after initial management at a local center within 3 days of the index event
•Age less than or equal to 45 years
•Willing and able to provide informed consent and comply with study procedures.
Note: STEMI equivalents include Isolated true posterior MI Hyperacute T-waves De Winter sign and MI in patients with an implanted pacemaker (PPI)
ExclusionCriteria
Details
• Patients who were on an investigational drug or had participated in a clinical trial in the previous 3 months
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Incidence of cumulative all-cause 1-year mortality in Indian patients with STEMI aged less than or equal to 45 years
Incidence of all-cause in-hospital mortality in young Indian patients (less than or equal to 45 years) due to STEMI at baseline
Baseline
Incidence of all-cause mortality at 30 days, 90 days, 180, and 365 days post baseline
30 days, 90 days, 180, and 365 days post baseline
Incidence of MACE [occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure hospitalization] at 30 days, 90 days, 180, and 365 days post baseline
30 days, 90 days, 180, and 365 days post baseline
Angiographic and angioplasty outcomes at baseline
Baseline
Assessment of in-hospital outcomes at baseline
Baseline
Assessment of management practice and Drug utilization pattern in the study population
Baseline to End of Study
Incidence of major adverse cardiovascular events (MACE) at 30 days, 90 days, 180, and 365 days from baseline stratified by age, gender, BMI, ASCVD risk factors, and comorbidity in young Indian patients (less than or equal to 45 years) with STEMI
30 days, 90 days, 180, and 365 days post baseline
Incidence of major bleeding events according to the Bleeding Academic Research Consortium (BARC) classification at baseline
Baseline
Proportion of patients with ASCVD risk factors such as hypertension, diabetes, and dyslipidemia at baseline, and stratified by age and gender
Baseline
Proportion of patients newly diagnosed with ASCVD risk factors such as hypertension, diabetes, and dyslipidemia at 30 days, 90 days, 180, and 365 days, and stratified by age and gender
30 days, 90 days, 180, and 365 days post baseline
Proportion of patients showing achievement of treatment targets based on the availability of clinical and laboratory data, such as
o HbA1c less than 7% at 90 days, 180, and 365 days from baseline
o LDL less than 55 mg/dL at 30 days, 90 days, 180, and 365 days from baseline
o Blood pressure less than 130/90 mmHg at 30 days, 90 days, 180, and 365 days from baseline
30 days, 90 days, 180, and 365 days post baseline
Change in Cardiac troponin (I/T) levels during the study period from baseline
Baseline to End of Study
Change in NTProBNP levels during the study period from baseline
Baseline to End of Study
Change in ECHO parameters during the study period from baseline
Total Sample Size="1500" Sample Size from India="1500" 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)
15/11/2025
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="2" 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
This is a multicenter, prospective, non-interventional, observational registry study. Young patients (aged less than or equal to 45 years) with STEMI who are directly referred to the study site or referred after initial management at a local center within 3 days of the index event, willing to provide informed consent, and meeting the eligibility criteria will be sequentially enrolled in the study across multiple sites in India.
On the day of screening/enrolment, i.e., baseline visit (Visit 1), demographic data, medical history, and clinical assessment will be recorded. Risk factor assessment will be performed based on comprehensive diagnostic evaluations, as per routine clinical practice, such as electrocardiograms (ECGs), ECHO parameters, biochemical markers (e.g., cardiac troponin, NT-proBNP), angiographic findings, and details of reperfusion interventions (e.g., primary percutaneous coronary intervention [PCI]), and outcomes will be captured. Follow-up visits will be planned at 30±15 days (Visit 2), 90±15 days (Visit 3), 180±15 days (Visit 4), and 365±15 days (Visit 5) from baseline. At each visit, the following evaluations are recommended to monitor clinical outcomes: assessment of cardiovascular risk factors (e.g., diabetes, hypertension, dyslipidemia), treatment adherence, and biomarker/laboratory profiles, including lipid levels, renal function, and blood glucose. The study intends to observe all the data variables as per the standard clinical practice of the investigators for the corresponding clinical profiles of each enrolled patient. The registry’s rigorously designed methodology is expected to yield critical insights into the clinical presentation, management patterns, and outcomes of young Indian adults with MI, supporting public health initiatives and improving standards of care for this high-risk population.
The data will be captured in the EDC and will be checked for accuracy and completeness.