Gender Differences in Prevention Strategies and Therapeutic Adherence After Acute Myocardial Infarction

NCT05619601 | Completed DMC

• 1 other identifier: 0099-2022-OBS
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 25

Brief 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.

Conditions

Gender Differences; Adherence, Medication; Therapeutic Adherence; Type 1 Acute Myocardial Infarction

Keywords

Gender; Adherence; Acute myocardial infarction

Outcome Measures

Primary Outcomes (3)

• Composite outcome of adherence to all secondary cardiovascular prevention recommendations at 12 months after discharge

  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)

  12 months

• Pharmacological primary endpoint

  Outcome of adherence to pharmacological therapies (MMAS-8) 12 months after discharge

  12 months

• Non-pharmacological primary endpoint

  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

  12 months

Secondary Outcomes (2)

• Pharmacological primary endpoint

  6 months

• Non-pharmacological primary endpoint

  6 months

Study Arms (2)

500 women

500 women discharged alive after a hospitalization for a type 1 acute myocardial infarction with significant coronary artery disease.

500 men

500 age (±2 years) and ECG (STEMI/NSTEMI) locally matched men discharged alive after a hospitalization for a type 1 acute myocardial infarction with significant coronary artery disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective, matched cohort study of patients hospitalized for a type 1 AMI 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 AMI with significant CAD. Comparator cohort: 500 age (±2 years) and ECG (STEMI/NSTEMI) locally matched men discharged alive after a hospitalization for a type 1 AMI with significant CAD.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Society of Cardiology: lead

Study Sites (25)

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Location

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, Spain

Location

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Location

Hospital Universitari Son Espases, Palma de Mallorca

Palma de Mallorca, Balearic Islands, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Barcelona, Spain

Location

Hospital Universitario Vall´d Hebron

Barcelona, Barcelona, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, Cáceres, Spain

Location

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Location

Complejo Asistencial Universitario de León

León, León, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Location

Hospital Álvaro Cunqueiro de Vigo

Vigo, Pontevedra, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Location

Complejo Hospitalario Universitario de Canarias, La Laguna

San Cristóbal de La Laguna, Tenerife, Spain

Location

Complejo Hospitalario de Toledo

Toledo, Toledo, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Location

Hospital Universitario de Áraba/Txagorritxu

Vitoria-Gasteiz, Vitoria, Spain

Location

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, Spain

Location

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  PMID: 33836996 RESULT

MeSH Terms

Conditions

Medication Adherence; Treatment Adherence and Compliance; Coitus

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Behavior; Sexual Behavior

Study Officials

• Hector Bueno, MD, PhD

  Hospital Universitario 12 de Octubre, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: March 8, 2023
• Primary Completion: January 18, 2026
• Study Completion: January 18, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (25)