Terminé

WAMIFProspective Registry in Young Women Presenting Acute Myocardial Infarction in France: Clinical, Morphological and Biological Descriptive Analysis: WAMIF Study

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Specific blood sample of women under 50 years with acute MI

Autre
Qui peut participer

Maladies Cardiovasculaires+7

+ Maladies Cardiaques

+ Infarctus

De 18 à 50 ans
+10 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Autre étude

Interventionnel
Date de début : mai 2017
Voir le détail du protocole

Résumé

Sponsor principalFrench Cardiology Society
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 4 mai 2017

Date à laquelle le premier participant a commencé l'étude.

Cardiovascular disease is the leading cause of death among women in France. In-hospital mortality after acute coronary syndrome (ACS) remains significantly higher than in men, with a relative risk of up to 150%, especially among young women1,2. Early mortality rate of myocardial infarction (MI) continues to decline but that of women remains higher. Background The risk of ACS increases with age, especially after menopause and in the presence of classic cardiovascular risk factors such as hypertension or diabetes. Nevertheless premenopausal women presenting MI are not exceptional even in the absence of risk factors. The worse prognosis in women, particularly in individuals under 50 years could result from the combination of harsher clinical presentation, less typical symptoms, and delayed diagnosis. Moreover, it is not uncommon that an ACS occurs in young women without the usual risk factors. Hormonal changes in particular related to contraceptive treatments have been incriminated, likewise chronic inflammation related to systemic diseases. To date the impact of hormonal, inflammatory or thrombophilia changes has not been elucidated. Nowadays use of endovascular imaging during diagnostic coronary angiography is become common practice in particular in the absence of obvious culprit thrombotic or obstructive lesion. These invasive imaging techniques such as intravascular ultrasound (IVUS) or OCT (Optical Coherence Tomography), bring highly relevant complementary information in this setting, particularly to clarify the mechanism of MI such as rupture or erosion of atherosclerotic plaque, spontaneous dissection or intramural hematoma. The incidence of these particular form of acute coronary artery lesions are higher in women, especially among the youngest one. In young, an angioCT or angioMRI (aortic and/or cerebral) are often performed looking for other atherosclerotic risk locations or morphological abnormalities in favour of a particular disease such as a fibrodysplasia. PET scan (18FDGlusose scintigraphy), when available, provides a valuable complement: it is a functional imaging research for other arterial locations for hypermetabolic inflammatory arteritis. Usual laboratory tests will be made at admission and discharge as done in routine practice. These tests include blood count, electrolytes, blood urea, creatinine, prothrombin time, activated partial thromboplastin time, glucose, HbA1C, lipide profil, hemoglobin electrophoresis, CRP, fibrinogen. Moreover some tests are recommended in case of ACS in a young patient not made systematically. It is the objective of our work to make a comprehensive and systematic analyse. Some assays require special techniques, to avoid any variability and therefore bias in interpretation of results, those will be, after preparation of the samples in the original department, centralized: such as homocysteine, markers of thrombophilia and hormone assays. Individually, these markers have been associated with the presence and progression of atheroma. However, these assays are rarely made and have not been comprehensively and systematically studied in the population of young woman presenting MI. Moreover it has long been accepted that women were less exposed than men to the risk of cardiovascular disease due to the protective role of oestrogen. However this assumption has been questioned by recent work on the hormonal treatment of menopause. The administration of oestrogen does not prevent ischemic arterial disease in postmenopausal women and may even be deleterious in older women. Then it then appears crucial to analyse hormone levels in the acute phase of MI in order to progress in the understanding of the hormonal role in ACS, so far this has never been made in this context. Study design This is a prospective multicentric observational clinical study. All women under 50 years admitted in one of the 32 participating centres, for acute MI, with and without ST segment elevation, will be included. Experimental plan * For any women admitted for acute MI with or without ST segment elevation in an investigation centre, participation in the study will be proposed. * Coronary angiography will be performed in emergency at admission according to current guidelines in case of STEMI. In case of NSTEMI, patients will benefit from coronary angiography according to defined risk stratification. * An IVUS imaging will be done in centers that practice this technique, the data will be collected as part of the study. This imaging will be performed if possible during the initial coronary angiography in order to objectify intraluminal thrombus, plaque rupture, hematoma or spontaneous dissection. This diagnostic strategy is carried out in common practice in the participating centers in atypical situations, particularly in the absence of obstructive lesion or visible thrombus at angiography. OCT may be carried out in a second step after mechanical and/or pharmacological thrombectomy in order to improve sensitivity. * Participation in the study will be proposed and agreement will be signed before discharge. * In the centers performing cardiac MRI, the MRI data will be collected as part of the study. Cardiac MRI will be done at the earliest after coronary angiography during the same hospitalization. * The usual blood tests will be performed at the patient's admission and then repeated at least 24 hours after coronary angiography, including repeated sampling assays for troponin, in order to measure the peak, following the routine of the department * The specific assays, corresponding to the tests carried out as part of the WAMIF study will be sampled before discharge. * During one of these blood samples a 5 ml sample of blood will be made for later analysis in the context of a serum bank. * Some assays, including hormonal and thrombophilia will be centralized in order to standardize the results and their interpretation * A second angiography associated with a challenge test by Methergin® can be planned, at the discretion of the referring cardiologist, within 5 days after the index event. This test will be especially recommended if no etiology has been found by OCT or MRI in order to diagnose a spastic angina. The test will be performed during coronary angiography with intravenous injection of 0.4 mg of Methergin® (méthylergotamine) followed by a control angiography 3 minutes followed by a test after intracoronary injection of nitrates. * All the data will be collected locally with the help of clinical studies technicians from the WAMIF study * All the biological data will be pooled and analyzed by IVS * The data management will be performed by the clinical research assistant from the SFC * A telephone interview will be conducted at 12 months to collect the major cardiovascular events (death from any cause, cardiovascular death, recurrent MI, stent thrombosis, stroke and major bleeding). These events will be specified through hospital reports. Total study duration: 18 months + follow up at to 12 months: 30 months Inclusion period: 18 months Duration of participation for one patient: 12 months Number of participating centers: 32 Average number of inclusions per month per center: 0.5 to 1

Titre officielProspective Registry in Young Women Presenting Acute Myocardial Infarction in France: Clinical, Morphological and Biological Descriptive Analysis: WAMIF Study
Sponsor principalFrench Cardiology Society
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

324 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Autre

Cette catégorie concerne les études qui ne relèvent d'aucune des catégories précédentes. Cela peut inclure des recherches innovantes, de nouvelles technologies ou des domaines émergents de la santé.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Femme

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 50 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies CardiovasculairesMaladies CardiaquesInfarctusIschémieInfarctus du MyocardeNécroseProcessus pathologiquesConditions pathologiques, signes et symptômesMaladies vasculairesIschémie myocardique

Critères

6 critères d'inclusion nécessaires pour participer
Women over 18 and under 50 years of age

Women admitted for MI defined by significant release of biological markers of myocardial necrosis associated with one of the following signs: chest pain and / or ECG abnormalities and / or loss of viable myocardium in imaging and / or thrombus to coronary angiography

Coronary angiography performed

Patient not objecting to the use of personal data.

Voir plus de critères

4 critères d'exclusion empêchent la participation
Iatrogenic MI and those of patients who died before hospitalization

Other causes of chest pain syndrome with elevated troponin, including myocarditis, Tako Tsubo, sepsis will be excluded after performing an MRI.

Participation in other biomedical research protocol excluding registers

Linguistic or mental disability or refusal to sign the informed consent

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

this clinical study is to systematically pool clinical, morphological and biological data of young women (\< 50 years) presenting an Acute MI and to assess their short-term (in-hospital) and mid-term (12 months) prognosis. The usual blood tests will be performed at the patient's admission and then repeated at least 24 hours after coronary angiography, including repeated sampling assays for troponin, in order to measure the peak, following the routine of the department The specific assays, corresponding to the tests carried out as part of the WAMIF study will be sampled before discharge.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 29 sites

Suspendu

Chu Amiens Picardie

Amiens, FranceOuvrir Chu Amiens Picardie dans Google Maps
Suspendu

Centre Hospitalier Annecy Genevois

Annecy, France
Suspendu

Centre Hospitalier D'Antibes Juan-Les-Pins

Antibes, France
Suspendu

Centre Hospitalier D'Argenteuil

Argenteuil, France
Terminé29 Centres d'Étude