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

April 23, 2024 updated by: Héctor Bueno, Spanish Society of Cardiology

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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:

1) 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.

1b. Proportion of patients adherent to all recommended non-pharmacological secondary prevention therapies at 6 and 12 months.

2) The relationship of the adherence with control of risk factors, clinical outcomes, and use of healthcare resources.

2a. The proportion of patients with optimal control of all cardiovascular risk factors at 6 and 12 months.

2b. The incidence of clinical outcomes at 6 and 12 months. 2c. The cumulative use of healthcare resources and cost after discharge.

3) To assess the factors associated with non-adherence to recommended secondary prevention therapies, with special emphasis to socioeconomic factors and gender issues.

STUDY DESIGN

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.

RECRUITMENT:

Participant centers:

25 hospitals managing routinely acute myocardial infarction and representing different regions from Spain will be invited to participate.

Patient recruitment:

All consecutive women fulfilling all inclusion criteria and without exclusion criteria surviving the index hospitalization will be invited to participate. Subsequently, men with inclusion criteria and without exclusion criteria, matched for age and ECG presentation, will be recruited.

STATISTICAL ANALYSIS:

A minimum sample size of 820 participants (410 per group) was estimated for an expected relative difference in recommendations compliance of the all-or-none composite primary outcome of 20%. An α error of 0.05 and a β error of 0.20 were considered for the sample size. The recommendations compliance was estimated as 42% for women and 52% for men. With the consideration of 20% of lost to follow-up (discontinuations) the total sample size is 984 patients, which is rounded out to 1000 patients (500 women and 500 men). To increase regional representation and allow exploration of potential regional variability, 25 hospitals from all regions in Spain (17 Autonomous Communities) will be invited to participate.

For the description of continuous variables, mean and standard deviation, or median and interquartile range will be used for Gaussian and non-normal distributions, respectively. For describing categorical variables, frequencies and percentages per category will be used. Categorical variables will be compared using the chi2 test, whilst continuous variables will be compared using the student t test.

Logistic regression models will be used to evaluate differences in binary outcomes between women and men (in hospital acute myocardial infarction management, post discharge myocardial infarction management). All subjects will be assumed to have a fixed follow-up (12±1 month). Multivariate adjusted models will be used to address any potential confounding in the associations between sex and each of the outcomes. Covariates will be selected based on their pre-defined clinical value and the unbalances observed across groups in the univariate analyses. Linear, multinomial or ordinal regression models would be used in case of continuous, categorical, or ordinal outcomes, respectively.

In addition to the models evaluating the association between sex and outcomes, a predictive model will be conducted to set predictors for the following outcomes:

  1. a composite of all preventive therapies (all-or-nothing for diet, physical activity, P2Y12 inhibitors, statins, and beta blockers or angiotensin converting enzyme inhibitors [if prescribed at discharge]), and
  2. each group of preventive interventions (drugs, cardiac rehab, diet, physical activity) Candidate predictors are classified as biological factors (age, sex, risk factors, comorbidities), disease-related (type of myocardial infarction: ST-segment elevation acute myocardial infarction (STEMI) / non-ST-segment elevation acute myocardial infarction (NSTEMI), left ventricular ejection fraction, number of vessels…), pharmacological factors (daily number of drugs, daily number of doses, specific drugs), socio-economic factors (zip code, education level, employment status, wages…) and specific gender issues (family responsibilities, work conciliation…). Special consideration will be given to age due to the high figures of in-hospital mortality in young women.

For women-specific analysis, female specific factors (menarche age, pregnancies, gestational diabetes, menopause…) will be considered.

It will be used the Clinical Outcomes, HEalthcare REsource UtilizatioN, and relaTed costs (COHERENT) model to study the hospital-related healthcare resources (emergency department visits, specialist visits, re-hospitalizations and urgent procedures) and costs.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Albacete, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Albacete
        • Contact:
          • José Miguel Corbí Pascual
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Alicante
        • Contact:
          • Miriam Sandín Rollán
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitario de Bellvitge
        • Contact:
          • Albert Ariza
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitario Vall´d Hebron
        • Contact:
          • Antonia Sambola Ayala
      • Cáceres, Spain
        • Recruiting
        • Hospital San Pedro de Alcantara
        • Contact:
          • José Javier Gómez Barrado
      • León, Spain
        • Recruiting
        • Complejo Asistencial Universitario de León
        • Contact:
          • Norberto Alonso Orcajo
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Lourdes Vicent Alaminos
      • Murcia, Spain
        • Recruiting
        • Hospital Universitario Virgen de La Arrixaca
        • Contact:
          • Domingo Pascual Figal
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Juan José Gómez Doblas
      • Salamanca, Spain
        • Recruiting
        • Hospital Clinico Universitario de Salamanca
        • Contact:
          • Ana Elvira Laffond
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • María del Mar Martínez Quesada
      • Toledo, Spain
        • Recruiting
        • Complejo Hospitalario de Toledo
        • Contact:
          • Marta Álvarez Sánchez
      • Valencia, Spain
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
          • Juan Sanchís Fores
      • Zaragoza, Spain
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
          • Pablo Revilla Martí
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain
        • Recruiting
        • Hospital Universitario de Santiago de Compostela
        • Contact:
          • Milagros Pedreira Pérez
    • Asturias
      • Oviedo, Asturias, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Rut Álvarez Velasco
    • Baleares
      • Palma de Mallorca, Baleares, Spain
        • Recruiting
        • Hospital Universitari Son Espases, Palma de Mallorca
        • Contact:
          • Xavier Roselló Lozano
    • Cantabria
      • Santander, Cantabria, Spain
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
          • Gonzalo Martín Gorria
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain
        • Recruiting
        • Hospital Universitario de Gran Canaria Dr. Negrin
        • Contact:
          • Rafaela Ramírez Rodríguez
    • Madrid
      • Alcorcón, Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Contact:
          • Raquel Campuzano Ruiz
    • Navarra
      • Pamplona, Navarra, Spain
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Aitziber Munarriz Arizcuren
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • Recruiting
        • Hospital Álvaro Cunqueiro de Vigo
        • Contact:
          • Sergio Raposeiras Roubín
    • Tenerife
      • La Laguna, Tenerife, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Canarias, La Laguna
        • Contact:
          • Pablo Jorge Pérez
    • Vitoria
      • Gasteiz / Vitoria, Vitoria, Spain
        • Recruiting
        • Hospital Universitario de Áraba/Txagorritxu
        • Contact:
          • Lucas Tojal Sierra
    • Vizcaya
      • Bilbao, Vizcaya, Spain
        • Recruiting
        • Hospital Universitario de Basurto
        • Contact:
          • Abel Andrés Morist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 applies
  • Signed informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome of adherence to all secondary cardiovascular prevention recommendations at 12 months after discharge
Time Frame: 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)
12 months
Pharmacological primary endpoint
Time Frame: 12 months
Outcome of adherence to pharmacological therapies (MMAS-8) 12 months after discharge
12 months
Non-pharmacological primary endpoint
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacological primary endpoint
Time Frame: 6 months
Outcome of adherence to pharmacological therapies (MMAS-8) 6 months after discharge
6 months
Non-pharmacological primary endpoint
Time Frame: 6 months
Composite outcome of adherence to non-pharmacological secondary cardiovascular prevention recommendations 6 months after discharge, including diet, physical activity and participation in cardiac rehabilitation programs
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Cardiology

Investigators

  • Principal Investigator: Hector Bueno, MD, PhD, Hospital Universitario 12 de Octubre, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0099-2022-OBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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