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NCT05619601
Gender Differences in Prevention Strategies and Therapeutic Adherence After Acute Myocardial Infarction
Conditions: Gender Differences, Adherence, Medication, Therapeutic Adherence, Type 1 Acute Myocardial Infarction
Sex: All
Ages: 18 Years – N/A
Enrollment: 1000
Sponsor: Spanish Society of Cardiology
Summary
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.- Reference cohort: 500 women discharged alive after a hospitalization for a type 1 acute myocardial infarction with significant coronary artery disease.- 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.
Eligibility Criteria
Inclusion Criteria: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 appliesSigned informed consentExclusion Criteria:Terminal disease (expected survival <12 months)Unavailable for 12-month follow-up (i.e.: living abroad, social situation…)Does not speak SpanishMajor active comorbidity (severe renal or liver failure, active cancer requiring chemotherapy…), interfering with regular post-myocardial infarction management
Source: ClinicalTrials.gov (NCT05619601). StuddyBuddy aggregates publicly available trial information.