Gender Differences in Prevention Strategies and Therapeutic Adherence After Acute Myocardial Infarction - GENAMI PREVENTION
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 25
- 主要终点
- Pharmacological primary endpoint
研究概览
简要总结
PARTICIPANT CENTERS: 25 hospitals managing routinely acute myocardial infarction (AMI) and representing different regions from Spain will be invited to participate.
GENERAL OBJECTIVE: To evaluate if there are differences in the level of adherence to recommended secondary prevention therapies (pharmacological and non-pharmacological) between women and men surviving a type 1 acute myocardial infarction (with obstructive coronary artery disease), its potential consequences, and the potential factors related to that difference, if present.
DESIGN:
Prospective, matched cohort study of patients hospitalized for a type 1 acute myocardial infarction with evidence of obstructive coronary artery disease who are discharged home alive. Women will be enrolled first, ideally in a consecutive manner, as they are the focus of the study. Men will be recruited subsequently as the comparison group, with 1:1 matching for age and ECG presentation. Matching will be performed locally, in each study site (hospital). All patients will undergo 1-year follow-up with clinical and therapeutic adherence evaluation.
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Reference cohort: 500 women discharged alive after a hospitalization for a type 1 acute myocardial infarction with significant coronary artery disease.
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Comparator cohort: 500 age (±2 years) and ECG (ST-segment elevation acute myocardial infarction (STEMI) / non-ST-segment elevation acute myocardial infarction (NSTEMI)) locally matched men discharged alive after a hospitalization for a type 1 acute myocardial infarction with significant coronary artery disease.
详细描述
OBJECTIVES
General objective: To evaluate if there are differences in the level of adherence to recommended secondary prevention therapies (pharmacological and non-pharmacological) between women and men surviving a type 1 acute myocardial infarction (with obstructive coronary artery disease), its potential consequences, and the potential factors related to that difference, if present.
Specific objectives: To compare between women and men:
- The adherence to recommended secondary prevention therapies at 6 months and 12 months measured as the:
1a. Proportion of patients adherent to all recommended pharmacological secondary prevention therapies at 6 and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization for a type 1 acute myocardial infarction (detection of a rise and/or fall of troponin c value above the 99th percentile upper reference limit (URL) and with at least one of the followings: symptoms of acute myocardial ischemia; new ischaemic ECG changes; development of pathological Q waves; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a patterns consistent with an ischaemic aetiology; identification of a coronary thrombus by angiography including intracoronary imaging)
- •Presence of obstructive coronary artery disease (CAD) (i.e. coronary artery stenosis ≥50%)
- •Age >18 years. No maximal age limit applies
- •Signed informed consent
排除标准
- •Terminal disease (expected survival <12 months)
- •Unavailable for 12-month follow-up (i.e.: living abroad, social situation...)
- •Does not speak Spanish
- •Major active comorbidity (severe renal or liver failure, active cancer requiring chemotherapy...), interfering with regular post-myocardial infarction management
结局指标
主要结局
Pharmacological primary endpoint
时间窗: 12 months
Outcome of adherence to pharmacological therapies (MMAS-8) 12 months after discharge
Non-pharmacological primary endpoint
时间窗: 12 months
Composite outcome of adherence to non-pharmacological secondary cardiovascular prevention recommendations 12 months after discharge, including diet, physical activity and participation in cardiac rehabilitation programs
Composite outcome of adherence to all secondary cardiovascular prevention recommendations at 12 months after discharge
时间窗: 12 months
The composite is built as an all-or-nothing response to an adherence ≥80% in all prescribed components of the endpoint: pharmacological therapies (MMAS-8), diet, physical activity and participation in a cardiac rehabilitation program. Adherence will be defined as having at least 80% compliance with all cardiovascular prevention recommendations; drugs, cardiac rehabilitation program, diet and physical activity)
次要结局
- Pharmacological primary endpoint(6 months)
- Non-pharmacological primary endpoint(6 months)
研究者
Héctor Bueno
Principal Investigator
Spanish Society of Cardiology