Hôpital de la Pitié Salpétrière
Paris, 75012, France
Location status: Recruiting
Location contact
Stéphane MANZO-SILBERMANN, MD
CONTACT
NCT Number: NCT07181317
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.
Interested in participating?
Request Info18 year–60 year
Female
Observational
Paris, 75012, France
Location status: Recruiting
Stéphane MANZO-SILBERMANN, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Assessment of stress and anxiety and quality of life after myocardial infarct:
Collection of information related to major events occurring since inclusion in the WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who died from any cause since their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who died from cardiovascular cause since their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had stent thrombosis since their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had stroke since their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had recurrent myocardial infarct since their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had emergency revascularization since their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had since major bleeding their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had emergency hospitalization for heart failure since their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who went to emergency department since their participation in WAMIF study
Time frame: 5 to 10 years after the participation in WAMIF study
Perceived Stress Scale 4 items. It provides a total score (range 10-50, from worst to best) to assess the state of stress perceived by the patient
Time frame: 5 to 10 years after the participation in WAMIF study
Generalized Anxiety Disorder 7 items. It provides a total score to evaluate patient anxiety (range 0 to 21: 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety)
Time frame: 5 to 10 years after the participation in WAMIF study
Patient Health Questionnaire 9 items. It provides a total score (range 0-27, 1-4 minimal depression; 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; 20-27 severe depression) to diagnose and measure severity of depression.
Time frame: 5 to 10 years after the participation in WAMIF study
European Quality of Life 5 Dimensions. It provides a total score (range 0-100, from worst to the best) to evaluate the generic quality of life
Time frame: 5 to 10 years after the participation in WAMIF study
12 Item Short Form General Health Survey. It determines a respondent's profile in eight fields: physical function, physical role, physical pain, general health, vitality, social functioning, emotional role, and mental health
Contact information is provided by the study sponsor or research team.
French Cardiology Society
Other
WAMIF: Prospective Study in Young Women Presenting Acute Myocardial Infarction in France: Clinical, Morphological and Biological Descriptive Analysis: Cohort Follow up
Acronym: WAMIF-suivi
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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