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Gender DifferencesGENAMINCT05619601

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

An observational study of Gender Differences and Adherence, Medication, run by Spanish Society of Cardiology at 25 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
530 participants
Where
25 sitesSpain
Study dates
8 Mar 2023to 18 Jan 2026
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Spain25 sites

  • Complejo Hospitalario Universitario de Albacete

    Albacete, Albacete

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid

  • Hospital General Universitario de Alicante

    Alicante, Alicante

  • Hospital Universitario de Bellvitge

    Barcelona, Barcelona

  • Hospital Universitario Vall´d Hebron

    Barcelona, Barcelona

  • Hospital Universitario de Basurto

    Bilbao, Vizcaya

  • Hospital San Pedro de Alcántara

    Cáceres, Cáceres

  • Hospital Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, Las Palmas

  • Complejo Asistencial Universitario de León

    León, León

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, Murcia

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias

  • Hospital Universitari Son Espases, Palma de Mallorca

    Palma de Mallorca, Balearic Islands

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre

  • Hospital Clínico Universitario de Salamanca

    Salamanca, Salamanca

  • Complejo Hospitalario Universitario de Canarias, La Laguna

    San Cristóbal de La Laguna, Tenerife

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria

  • Hospital Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla

  • Complejo Hospitalario de Toledo

    Toledo, Toledo

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia

  • Hospital Álvaro Cunqueiro de Vigo

    Vigo, Pontevedra

  • Hospital Universitario de Áraba/Txagorritxu

    Vitoria-Gasteiz, Vitoria

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Zaragoza

Other trials in Spain

About this study

Official title: 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.

Read more

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.
Read the 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.

  1. 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.

  1. 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.

Keywords
Gender, Adherence, Acute myocardial infarction
Medical subject headings
Medication Adherence, Treatment Adherence and Compliance, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05619601
Study groupRoleWhat they receive
500 women500 women discharged alive after a hospitalization for a type 1 acute myocardial infarction with significant coronary artery disease.
500 men500 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 12 months

  2. Pharmacological primary endpoint

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

    Measured: 12 months

  3. 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

    Measured: 12 months

Secondary outcomes (2)

  1. Pharmacological primary endpoint

    Outcome of adherence to pharmacological therapies (MMAS-8) 6 months after discharge

    Measured: 6 months

  2. Non-pharmacological primary endpoint

    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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2022
  2. Study start8 Mar 2023
  3. Primary completion18 Jan 2026
  4. Study completion18 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
530 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619601
Sponsor's protocol ID
0099-2022-OBS
Acronym
GENAMI
Status last verified
Apr 2026
First submitted
9 Nov 2022
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nowbar AN, Gitto M, Howard JP, Francis DP, Al-Lamee R. Mortality From Ischemic Heart Disease. Circ Cardiovasc Qual Outcomes. 2019 Jun;12(6):e005375. doi: 10.1161/CIRCOUTCOMES.118.005375. Epub 2019 Jun 4.

    PubMed 31163980

  • Maas AHEM, Rosano G, Cifkova R, Chieffo A, van Dijken D, Hamoda H, Kunadian V, Laan E, Lambrinoudaki I, Maclaran K, Panay N, Stevenson JC, van Trotsenburg M, Collins P. Cardiovascular health after menopause transition, pregnancy disorders, and other gynaecologic conditions: a consensus document from European cardiologists, gynaecologists, and endocrinologists. Eur Heart J. 2021 Mar 7;42(10):967-984. doi: 10.1093/eurheartj/ehaa1044.

    PubMed 33495787

  • Jagannathan R, Patel SA, Ali MK, Narayan KMV. Global Updates on Cardiovascular Disease Mortality Trends and Attribution of Traditional Risk Factors. Curr Diab Rep. 2019 Jun 20;19(7):44. doi: 10.1007/s11892-019-1161-2.

    PubMed 31222515

  • Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.

    PubMed 30700139

  • Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010 Jun 10;362(23):2155-65. doi: 10.1056/NEJMoa0908610.

    PubMed 20558366

  • Neumann JT, Gossling A, Sorensen NA, Blankenberg S, Magnussen C, Westermann D. Temporal trends in incidence and outcome of acute coronary syndrome. Clin Res Cardiol. 2020 Sep;109(9):1186-1192. doi: 10.1007/s00392-020-01612-1. Epub 2020 Feb 7.

    PubMed 32034482

  • Chi GC, Kanter MH, Li BH, Qian L, Reading SR, Harrison TN, Jacobsen SJ, Scott RD, Cavendish JJ, Lawrence JM, Tartof SY, Reynolds K. Trends in Acute Myocardial Infarction by Race and Ethnicity. J Am Heart Assoc. 2020 Mar 3;9(5):e013542. doi: 10.1161/JAHA.119.013542. Epub 2020 Mar 2.

    PubMed 32114888

  • Goldberg RJ, Tisminetzky M, Tran HV, Yarzebski J, Lessard D, Gore JM. Decade Long Trends (2001-2011) in the Incidence Rates of Initial Acute Myocardial Infarction. Am J Cardiol. 2019 Jan 15;123(2):206-211. doi: 10.1016/j.amjcard.2018.10.002. Epub 2018 Oct 19.

    PubMed 30409411

  • Bangalore S, Fonarow GC, Peterson ED, Hellkamp AS, Hernandez AF, Laskey W, Peacock WF, Cannon CP, Schwamm LH, Bhatt DL; Get with the Guidelines Steering Committee and Investigators. Age and gender differences in quality of care and outcomes for patients with ST-segment elevation myocardial infarction. Am J Med. 2012 Oct;125(10):1000-9. doi: 10.1016/j.amjmed.2011.11.016. Epub 2012 Jun 27.

    PubMed 22748404

  • Bossard M, Latifi Y, Fabbri M, Kurmann R, Brinkert M, Wolfrum M, Berte B, Cuculi F, Toggweiler S, Kobza R, Chamberlain AM, Moccetti F. Increasing Mortality From Premature Coronary Artery Disease in Women in the Rural United States. J Am Heart Assoc. 2020 May 5;9(9):e015334. doi: 10.1161/JAHA.119.015334. Epub 2020 Apr 22.

    PubMed 32316803

  • Arora S, Stouffer GA, Kucharska-Newton AM, Qamar A, Vaduganathan M, Pandey A, Porterfield D, Blankstein R, Rosamond WD, Bhatt DL, Caughey MC. Twenty Year Trends and Sex Differences in Young Adults Hospitalized With Acute Myocardial Infarction. Circulation. 2019 Feb 19;139(8):1047-1056. doi: 10.1161/CIRCULATIONAHA.118.037137.

    PubMed 30586725

  • Wu WY, Berman AN, Biery DW, Blankstein R. Recent trends in acute myocardial infarction among the young. Curr Opin Cardiol. 2020 Sep;35(5):524-530. doi: 10.1097/HCO.0000000000000781.

    PubMed 32694263

  • Rodriguez-Padial L, Fernandez-Perez C, Bernal JL, Anguita M, Sambola A, Fernandez-Ortiz A, Elola FJ. Differences in in-hospital mortality after STEMI versus NSTEMI by sex. Eleven-year trend in the Spanish National Health Service. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):510-517. doi: 10.1016/j.rec.2020.04.017. Epub 2020 Jun 16. English, Spanish.

    PubMed 32561143

  • Cortes-Beringola A, Fitzsimons D, Pelliccia A, Moreno G, Martin-Asenjo R, Bueno H. Planning secondary prevention: Room for improvement. Eur J Prev Cardiol. 2017 Jun;24(3_suppl):22-28. doi: 10.1177/2047487317704954.

    PubMed 28618903

  • Mehta LS, Beckie TM, DeVon HA, Grines CL, Krumholz HM, Johnson MN, Lindley KJ, Vaccarino V, Wang TY, Watson KE, Wenger NK; American Heart Association Cardiovascular Disease in Women and Special Populations Committee of the Council on Clinical Cardiology, Council on Epidemiology and Prevention, Council on Cardiovascular and Stroke Nursing, and Council on Quality of Care and Outcomes Research. Acute Myocardial Infarction in Women: A Scientific Statement From the American Heart Association. Circulation. 2016 Mar 1;133(9):916-47. doi: 10.1161/CIR.0000000000000351. Epub 2016 Jan 25.

    PubMed 26811316

Questions about this trial

What is this clinical trial studying?

An observational study of Gender Differences and Adherence, Medication, run by Spanish Society of Cardiology at 25 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome of adherence to all secondary cardiovascular prevention recommendations at 12 months after discharge (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05619601, which also lists 80 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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