Cohort of STEMI Patients 2

Официальное название

CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction

Обзор

ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort). The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.

Вмешательства

• Другое MRI
  1 MRI at 1 month with gadolinium injection
• Биопрепарат Biocollection
  Biocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples.
• Поведенческое Quality of life questionaries
  EQ-5D-5L and HAD questionaries at 1 month and 1 year.

Первичные конечные точки

• Research of potential new markers [Срок оценки: 1 year]

Вторичные конечные точки (3)

• Calculation of infarct size on MRI [Срок оценки: 1 month]
• Pharmacoepidemiology of myocardial infarction. [Срок оценки: 5 years]
• Events between inclusion and 5 years follow-up [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
• Management in primary ACT
• Prior oral informed consent followed by signed informed consent as soon as possible.

Критерии исключения

• Diagnosis of STEMI not confirmed on angiography
• Inability to give the subject informed information
• Lack of coverage by a social security scheme
• Obvious contraindication to injected magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, or a metallic body (ferromagnetic), severe renal insufficiency (GFR<30 ml/min), known allergy to the contrast medium ....)
• Pregnant woman or woman of childbearing age without effective contraception, breastfeeding woman.
• Deprivation of civil rights (curators, guardianship, safeguard of justice)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 2 центра

• Hospices Civils de Lyon - Hôpital Louis Pradel — Bron
• Hospices Civils de Lyon - Hôpital de la Croix Rousse — Lyon

Публикации

• Stevic N, Pinede A, Mewton N, Ovize M, Argaud L, Lecour S, Boiteux C, Bochaton T, Cour M. Effect of ventricular fibrillation on infarct size after myocardial infarction: a translational study. Basic Res Cardiol. 2024 Dec;119(6):911-921. doi: 10.1007/s00395-024-01091-9. Epub 2024 Nov 23. PMID 39579225

Идентификаторы

NCT: NCT05794022 · 69HCL22_0991

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗