STEMI-45 Registry- A Pan-India, Multi-centric, Prospective, Noninterventional Study of Indian Young Adults with ST-Elevated Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Incidence of cumulative all-cause 1-year mortality in Indian patients with STEMI aged less than or equal to 45 years
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •• 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).
排除标准
- •Patients who were on an investigational drug or had participated in a clinical trial in the previous 3 months.
结局指标
主要结局
Incidence of cumulative all-cause 1-year mortality in Indian patients with STEMI aged less than or equal to 45 years
时间窗: 30 days, 90 days, 180, and 365 days post baseline
次要结局
- 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)
- 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)
- 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(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)
研究者
Dr Niteen Deshpande
Spandan Heart Institute and Research centre