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Идёт набор NCT07041840

ReModeling in ST-elevation myocARrdial Infarction: a Comparison of Left VEntricuLar Functions in Long-term Follow-up Among STEMI Patients

— Наблюдательное STEMI

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: STEMI. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

ReModeling in ST-elevation myocARrdial Infarction: a Comparison of Left VEntricuLar Functions in Long-term Follow-up Among STEMI Patients: The MARVEL Study

Обзор

Patients diagnosed with STEMI who underwent pPCI were included in this study. The investigators collected comprehensive data on each patient's status, including laboratory findings such as NT-proBNP, troponin levels, and inflammatory profile assessed by leukocyte count, C-reactive protein, interleukin-1, and interleukin-6. Additionally, electrocardiographic and echocardiographic features, details of the coronary intervention procedure, hospital stay duration, complications, and medical treatments were recorded. Comprehensive transthoracic echocardiograms (TTE) were performed at admission and before discharge. Myocardial tissue characterization was conducted by cardiac magnetic resonance (CMR) imaging before discharge, assessing intramyocardial hemorrhage (IMH), microvascular obstruction (MVO), infarct size (IS), area at risk (AAR), salvaged myocardium, and salvage index. At the six-month follow-up, laboratory tests, CMR imaging, and TTE were repeated, along with a thorough clinical evaluation. LVR was defined by one of the following criteria: a 20% increase in end-diastolic volume by TTE or 12% by CMR, a 15% increase in end-systolic volume, a sphericity index greater than 42% (CMR only), the emergence of new concentric hypertrophy, or a reduction greater than 10% in left ventricular ejection fraction (LVEF).

Подробное описание

Patients diagnosed with STEMI who underwent pPCI were included in this study. The investigators collected comprehensive data on each patient's status, including laboratory findings such as NT-proBNP, troponin levels, and inflammatory profile assessed by leukocyte count, C-reactive protein, interleukin-1, and interleukin-6. Additionally, electrocardiographic and echocardiographic features, details of the coronary intervention procedure, hospital stay duration, complications, and medical treatments were recorded.

Comprehensive transthoracic echocardiograms (TTE) were performed at admission and before discharge. Myocardial tissue characterization was conducted by cardiac magnetic resonance (CMR) imaging before discharge, assessing intramyocardial hemorrhage (IMH), microvascular obstruction (MVO), infarct size (IS), area at risk (AAR), salvaged myocardium, and salvage index.

At the six-month follow-up, laboratory tests, CMR imaging, and TTE were repeated, along with a thorough clinical evaluation. LVR was defined by one of the following criteria: a 20% increase in end-diastolic volume by TTE or 12% by CMR, a 15% increase in end-systolic volume, a sphericity index greater than 42% (CMR only), the emergence of new concentric hypertrophy, or a reduction greater than 10% in left ventricular ejection fraction (LVEF).

Первичные конечные точки

  • Remodeling [Срок оценки: 36 months]

Критерии участия

Критерии включения

  • STEMI

Критерии исключения

  • Contraindication to CMR imaging

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • University of Pisa, Cisanello Hospital — Pisa

Идентификаторы

NCT: NCT07041840 · MARVEL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗