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Идёт набор NCT07181317

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

— Наблюдательное Myocardial Infarction, Acute

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Questionnaires, Major events.
Кому может быть актуально
Состояния в реестре: Myocardial Infarction, Acute. Базовые параметры: 18 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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)
  • Другое Major events
    Collection of information related to major events occurring since inclusion in the WAMIF study

Первичные конечные точки

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

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital de la Pitié Salpétrière — Paris

Идентификаторы

NCT: NCT07181317 · 2025-04

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗