WAMIF : Young Women Presenting Acute Myocardial Infarction in France

NCT03073447 | Completed

• 1 other identifier: 2015-01
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 29

Brief 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

Keywords

Myocardial infarction; Women; Young; Primary PCI; Hormone

Outcome Measures

Primary Outcomes (1)

• the combined endpoint of major cardiovascular events

  The primary endpoint will be the combined endpoint of major cardiovascular events occurring during the index hospitalization: death from any cause, cardiovascular death, recurrent MI, stent thrombosis, stroke and major bleeding (defined as classified BARC 3 to 5).

  From date of randomization until the date of first documented date of death from any cause, cardiovascular death, recurrent MI, stent thrombosis, stroke and major bleeding, whichever came first, assessed up to discharge of the patient

Secondary Outcomes (9)

• Anatomical characteristics of culprit lesions

  from date of enrollment up to 12 months

• Frequency of the rare non atheromatous

  through study completion, an average of 1 year

• prevalence of classical cardiovascular risk factors

  through study completion, an average of 1 year

• Presence or absence of a higher prevalence of diseases related to inflammation or thrombophilia

  through study completion, an average of 1 year

• Influence of gynaecological and obstetrical status, hormonal parameters, and in particular hormonal profiles at risk: SHBG elevation

  through study completion, an average of 1 year

Study Arms (1)

women under 50 years with acute MI

OTHER

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.

Other: Specific blood sample of women under 50 years with acute MI

Interventions

Specific blood sample of women under 50 years with acute MI OTHER

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.

Also known as: specific assays

women under 50 years with acute MI

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Beneficiary of a social protection (excluding AME)
• Signature of informed consentement form

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead
• French Federation of Cardiology: collaborator
• I.V.S. Institut des Vaisseaux et du Sang: collaborator
• Biosensors Europe SA: collaborator
• AstraZeneca: collaborator
• Boston Scientific Corporation: collaborator
• Abbott Medical Devices: collaborator
• Terumo Corporation: collaborator
• Daiichi Sankyo: collaborator
• Hexacath, France: collaborator
• Biotronik SE & Co. KG: collaborator

Study Sites (29)

Chu Amiens Picardie

Amiens, 80000, France

Location

Centre Hospitalier Annecy Genevois

Annecy, 74000, France

Location

Centre Hospitalier D'Antibes Juan-Les-Pins

Antibes, 06160, France

Location

Centre Hospitalier D'Argenteuil

Argenteuil, 95100, France

Location

Centre Hospitalier D'Avignon

Avignon, 84000, France

Location

CHU de Beauvais

Beauvais, 60000, France

Location

Chru La Cavale Blanche

Brest, 29200, France

Location

Hopital Louis Pasteur

Chartres, 28000, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Chu Dijon

Dijon, 21000, France

Location

Chu Grenoble

Grenoble, France

Location

Centre Hospitalier de Haguenau

Haguenau, 67500, France

Location

Groupe Hospitalier de La Rochell

La Rochelle, 17000, France

Location

Chru de Lille

Lille, 59000, France

Location

Ch St Joseph St Luc

Lyon, 69000, France

Location

Chu Hopital Nord

Marseille, 13000, France

Location

Chu de Montpellier

Montpellier, 34000, France

Location

Chu de Nimes

Nîmes, 30000, France

Location

Centre Hospitalier Rene-Dubos

Paris, 75000, France

Location

Hôpital LARIBOISIERE

Paris, 75000, France

Location

Hôpital Universitaire Pitié-Salpêtrière

Paris, 75013, France

Location

Hopital Europeen Georges-Pompidou

Paris, 75015, France

Location

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

Chu de Rennes

Rennes, 35000, France

Location

Chu de Rouen

Rouen, 76000, France

Location

Clinique St Hilaire

Rouen, 76000, France

Location

Hotel-Dieu Saint-Jacques

Toulouse, 31000, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56000, France

Location

Centre Hospitalier de Versailles

Versailles, 78000, France

Location

Related Publications (1)

• Manzo-Silberman S, Couturaud F, Bellemain-Appaix A, Vautrin E, Gompel A, Drouet L, Marliere S, Sollier CBD, Uhry S, Eltchaninoff H, Bergot T, Motreff P, Lahlou N, Cottin Y, Mounier-Vehier C, Gilard M, Montalescot G; WAMIF Investigators. Characteristics of Young Women Presenting With Acute Myocardial Infarction: The Prospective, Multicenter, Observational Young Women Presenting Acute Myocardial Infarction in France Study. J Am Heart Assoc. 2024 Oct;13(19):e034456. doi: 10.1161/JAHA.124.034456. Epub 2024 Sep 25.

  PMID: 39319493 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Stéphane MANZO SILBERMAN

  Hôpital LARIBOISIERE PARIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: March 8, 2017
• Study Start: May 4, 2017
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (29)