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Recruiting NCT07181317

WAMIF: Prospective Study in Young Women Presenting Acute Myocardial Infarction: Cohort Follow up

— Observational Myocardial Infarction, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires, Major events.
Who it may be relevant to
Registry conditions: Myocardial Infarction, Acute. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

WAMIF: Prospective Study in Young Women Presenting Acute Myocardial Infarction in France: Clinical, Morphological and Biological Descriptive Analysis: Cohort Follow up

Overview

The WAMIF study was conducted from 2017 to 2019, including 314 patients in 30 French research centers spread across metropolitan France. It systematically collected the clinical, morphological, and biological characteristics of myocardial infarction cases affecting women under 50 years of age and assessed their short-term (in-hospital) and medium-term (12-month) prognosis. Extending the follow-up beyond 12 months for this first study would provide fundamental data for understanding and improving the care of these patients.

Detailed description

The WAMIF study was conducted from 2017 to 2019, including 314 patients in 30 French research centers spread across metropolitan France. It systematically collected the clinical, morphological, and biological characteristics of myocardial infarction cases affecting women under 50 years of age and assessed their short-term (in-hospital) and medium-term (12-month) prognosis. The main results were: a particularly high incidence of modifiable risk factors affecting 86% of patients, with smoking being the primary cause in 75% of them.The clinical presentation found chest pain in more than 90% of cases. The pathophysiological forms of acute coronary syndrome identified the culprit artery in 90% of cases, a form without obstruction (MINOCA) was found in 17.8% of ST segment elevation infarctions (STEMI), spontaneous dissection in 14.6% of STEMI and 16.3% of NSTEMI.At 12 months, follow-up showed no cardiovascular deaths and two deaths related to neoplastic causes. At the end of this follow-up, 90% had no events. Compared to existing studies, these event rates are extremely low. Extending the follow-up beyond 12 months for this first study would provide fundamental data for understanding and improving the care of these patients. The secondary objective is the evaluation of the quality of life and mental health of women who have had an MI before the age of 50 years at a distance from the acute event.

Interventions

  • Other Questionnaires
    Assessment of stress and anxiety and quality of life after myocardial infarct: * Stress score: Perceived Stress Scale-4 (PSS-4) * Anxiety score: Generalized Anxiety Disorder-7 (GAD-7) * Depression score: Patient Health Questionnaire-9 (PHQ-9) * Quality of life scores: European Quality of Life-5 Dimensions (EQ-5D) and 12-Item Short-Form General Health Survey (SF-12)
  • Other Major events
    Collection of information related to major events occurring since inclusion in the WAMIF study

Primary outcome measures

  • Death from any cause [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Cardiovascular death [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Stent thrombosis [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Stroke [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Recurrent myocardial infarct [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Emergency revascularization [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Major bleeding [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Emergency hospitalization for heart failure [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Emergency department visit [Time frame: 5 to 10 years after the participation in WAMIF study]
Secondary outcome measures (5)
  • Stress score [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Anxiety score [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Depression score [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Quality of life score [Time frame: 5 to 10 years after the participation in WAMIF study]
  • Quality of life score [Time frame: 5 to 10 years after the participation in WAMIF study]

Eligibility criteria

All patients who participated in the WAMIF study (research registration number with the French Ministry of Health : 2015-A01263-46 / Protocol registration with Clinical Trials NCT03073447) and wish to continue follow-up in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital de la Pitié Salpétrière — Paris

Identifiers

NCT: NCT07181317 · 2025-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗