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Идёт набор NCT04528511

BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction

— Наблюдательное Atrial Fibrillation New Onset Acute Myocardial Infarction

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: Continuous Electronic Monitor.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation New Onset, Acute Myocardial Infarction. Базовые параметры: от 18 лет · 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
Китай
Следующий шаг
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Официальное название

BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction: the BENEFIT-AMI Multicenter Prospective Registry

Обзор

To validate the prognostic importance of the burden of new-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) in a prospectively designed hospital-based registry. To characterize those factors that contribute to the progression of post-MI NOAF burden. To establish a prediction model for the risk stratification of patients with NOAF complicating AMI. To explore the clinical usefulness of NOAF burden in guiding the anticoagulation therapy among patients with post-MI NOAF.

Подробное описание

Our previously designed single-center retrospective cohort study (NCT03533543) suggested that patients with a greater burden of NOAF complicating AMI were challenged by a poor prognosis. In the present study, we aim to design a multicenter, prospective, hospital-based registry to validate the preceding findings. We plan to enroll patients who were admitted for AMI in 9 tertiary medical centers from Shanghai, Henan, and Zhejiang provinces and developed NOAF during the index hospitalization. All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, and medications will be collected. NOAF burden is calculated by dividing the total AF duration by the total continuous electronic monitoring (CEM) duration. Other NOAF related characteristics, such as AF pattern, AF frequency, and symptomatic or silent AF, and the longest AF episode duration will also be evaluated. All patients who are discharged alive will be followed for at least 2 years and cardiovascular outcomes will be recorded.

Вмешательства

  • Устройство Continuous Electronic Monitor
    All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

Первичные конечные точки

  • All-cause death [Срок оценки: up to 1 year]
Вторичные конечные точки (5)
  • Cardiovascular death [Срок оценки: up to 1 year]
  • Heart failure hospitalization [Срок оценки: up to 1 year]
  • Recurrent myocardial infarction [Срок оценки: up to 1 year]
  • Ischemic stroke [Срок оценки: up to 1 year]
  • Major bleeding [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

  • Adult patients (>18 years old);
  • Patient with AMI (including STEMI and NSTEMI) who developed NOAF during the index hospitalization;
  • Patients must have received in-hospital CEM for at least 5 days;
  • Patients must give informed consent.

Критерии исключения

  • Patients with a medical history of pre-existing AF;
  • Patients with a medical history of rheumatic valvular disease;
  • Patients with a medical history of sick sinus syndrome;
  • Patients undergoing emergent coronary artery bypass surgery;
  • Patients who suffer malignant tumors with an expected lifetime less than 1 year ;
  • Patients who refuse to receive CEM during hospitalization and the data of heart rhythm cannot be retrieved;
  • Patients who refuse to receive percutaneous coronary intervention (PCI) or have contraindications for PCI;
  • Patients who have died during the index hospitalization.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 5 центров
  • Kaifeng Central Hospital — Kaifeng
  • Luoyang Central Hospital — Luoyang
  • The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
  • Department of Cardiology, Shanghai Tenth People's Hospital — Шанхай
  • Shanghai Seventh People's Hospital — Шанхай

Идентификаторы

NCT: NCT04528511 · BENEFIT-AMI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗