Clinical trial NCT05619601: Gender Differences in Prevention Strategies and Therapeutic Adherence After Acute Myocardial Infarction
Official title: Gender Differences in Prevention Strategies and Therapeutic Adherence After Acute Myocardial Infarction - GENAMI PREVENTION
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gender Differences
Adherence, Medication
Therapeutic Adherence
Type 1 Acute Myocardial Infarction
Keywords: Gender
Adherence
Acute myocardial infarction
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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 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

Primary outcomes:
measure: Composite outcome of adherence to all secondary cardiovascular prevention recommendations at 12 months after discharge
timeFrame: 12 months
measure: Pharmacological primary endpoint
timeFrame: 12 months
measure: Non-pharmacological primary endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Pharmacological primary endpoint
timeFrame: 6 months
measure: Non-pharmacological primary endpoint
timeFrame: 6 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases, Palma de Mallorca
state: Baleares
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrín
state: Las Palmas
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro de Vigo
state: Pontevedra
city: La Laguna
country: Spain
facility: Complejo Hospitalario Universitario de Canarias, La Laguna
state: Tenerife
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario de Áraba/Txagorritxu
state: Vitoria
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Vizcaya
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitario Vall´d Hebron
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: Hospital Universitario 12 de Octubre, Madrid
name: Hector Bueno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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