Health Condition 1: I213- ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Sun Pharma Laboratories Limited (SPLL)
Eligibility
Inclusion criteria
Inclusion criteria: • 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)
Exclusion criteria
Exclusion criteria: • Patients who were on an investigational drug or had participated in a clinical trial in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of cumulative all-cause 1-year mortality in Indian patients with STEMI aged less than or equal to 45 yearsTimepoint: 30 days, 90 days, 180, and 365 days post baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 genderTimepoint: 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 baselineTimepoint: 30 days, 90 days, 180, and 365 days post baseline;Change in Cardiac troponin (I/T) levels during the study period from baselineTimepoint: Baseline to End of Study;Change in NTProBNP levels during the study period from baselineTimepoint: Baseline to End of Study;Change in ECHO parameters during the study period from baselineTimepoint: Baseline to End of Study;Incidence of all-cause in-hospital mortality in young Indian patients (less than or equal to 45 years) due to STEMI at baselineTimepoint: Baseline;Incidence of all-cause mortality at 30 days, 90 days, 180, and 365 days post baselineTimepoint: 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 baselineTimepoint: 30 days, 90 days, 180, and 365 days post baseline;Angiographic and angioplasty outcomes at baselineTimepoint: Baseline;Assessment of in-hospital outcomes at baselineTimepoint: Baseline;Assessment of management practice and Drug utilization pattern in the study populationTimepoint: 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 e | — |
Countries
India
Contacts
Public ContactDr Chintan Khandhedia
Sun Pharma Laboratories Limited
Outcome results
None listed