WAMIF : Young Women Presenting Acute Myocardial Infarction in France

Summary

MI in elderly women seems to share the same pathophysiology than in men, especially plaque rupture associated with conventional risk factors. Therefore the questions is not solved on the pathophysiology and specific risk factors in young women whose prognosis is more severe. A complete descriptive analysis appears mandatory to understand the peculiarities, including not only morphological but also biological explorations as well.

To date no systematic descriptive analysis has been performed including clinical characteristics, cardiac and extra-cardiac morphological exploration and hormonal and immunological assays, particularly in young premenopausal women presenting MI.

This study will provide for the first time a complete analysis, including hormonal assays, never made in an "acute" population.

The main objective of 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 definition of MI is the one adopted in the Third definition published in 2012. As such an event occurs in a young patient, diagnostic and treatment may vary among centres. The incidence of such cases in each centre being low and practice inhomogeneous, no conclusion could be advanced concerning the study of associated, indeed predisposing factors.

The work aims to comprehensively and systematically collect all the clinical and laboratory data and the results of the all morphological explorations carried out during the care of these young women admitted for acute MI in high-volume centres.

No additional invasive act, without any direct benefit for the care of patients will be realized for research purposes.

All these examinations, in particular invasive morphological, are more and more integrated in the practice of modern interventional cardiology especially for complex or infrequent situations, like this setting. They afford accurate diagnosis of coronary disease on one hand and on the second hand they determine the causal or at least participating factor.

A comprehensive and systematic analysis of this particular entity that is MI in young woman, would improve our knowledge of this disease and then enable to offer patients a more appropriate treatment and monitoring. It is necessary to progress in the understanding of the mechanisms of the early onset of coronary artery disease in its most acute and most serious presentation and to clearly define the specificities of coronary disease in young women. Moreover, a more precise identification of risk factors of MI in a woman under 50 will allow a better screening and even introduction of preventive strategies.

Conditions

• Acute Myocardial Infarction
• Women Over 18 and Under 50 Years of Age

Interventions

OTHER

Specific blood sample of women under 50 years with acute MI

The specific assays, corresponding to the tests carried out as part of the WAMIF study will be sampled before discharge. Some assays, including hormonal and thrombophilia will be centralized in order to standardize the results and their interpretation. All the biological data will be pooled and analyzed by IVS. a sample of blood will be made for later analysis in the context of a serum bank.

Sponsors & Collaborators

• French Federation of Cardiology

  collaborator OTHER

• I.V.S. Institut des Vaisseaux et du Sang

  collaborator UNKNOWN

• Biosensors Europe SA

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• Boston Scientific Corporation

  collaborator INDUSTRY

• Abbott Medical Devices

  collaborator INDUSTRY

• Terumo Corporation

  collaborator INDUSTRY

• Daiichi Sankyo

  collaborator INDUSTRY

• Hexacath, France

  collaborator INDUSTRY

• Biotronik SE & Co. KG

  collaborator INDUSTRY

• French Cardiology Society

  lead OTHER

Principal Investigators

• Stéphane MANZO SILBERMAN · Hôpital LARIBOISIERE PARIS

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-04

Primary Completion

2020-10-06

Completion

2020-10-06

Countries

• France

Study Locations