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Набор скоро начнётся NCT07688200

Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies

— Наблюдательное Arrhythmogenic Cardiomyopathy (AC, ARVD/C) Ventricular Tachycardia (VT) Ventricular Fibrillation ICD

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: Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT), Ventricular Fibrillation, ICD. 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
Список центров уточняется — проверьте первичный протокол.
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

Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies: A Multicenter Retrospective Observational Study

Обзор

TRACE-ACM is a multicenter, retrospective, observational study of patients with arrhythmogenic cardiomyopathy who received an implantable cardioverter-defibrillator (ICD) and had documented ventricular tachyarrhythmias. The study aims to describe the prevalence and type of ICD-related complications, characterize ventricular arrhythmias documented by ICD electrograms and/or ECG recordings, and explore associations between clinical, device-related, and treatment-related factors and arrhythmic outcomes.

Подробное описание

Patients with arrhythmogenic cardiomyopathy will be identified at participating centers with expertise in the diagnosis and management of arrhythmogenic cardiomyopathies. De-identified retrospective data will be collected, including demographics, arrhythmogenic cardiomyopathy phenotype, genetic data, ICD type and indication, clinical follow-up, ICD therapies, antiarrhythmic and heart failure therapies, catheter ablation, and ECG/ICD electrogram documentation of ventricular tachyarrhythmias.

ICD-related complications will include implant-related complications such as hematoma, perforation, pneumothorax, upper-limb deep vein thrombosis, lead failure, and infection, as well as non-implant-related complications such as inappropriate shocks. Ventricular arrhythmias will be classified as monomorphic ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation, or transition patterns between these arrhythmia types. When available, arrhythmia initiation will be analyzed using pre-specified ECG/EGM criteria including the origin of the beats preceding arrhythmia onset, R1-R2 and R2-R3 intervals, pause dependency, coupling interval, and prematurity index.

The study will also describe atrial arrhythmias and medical, interventional, and device-based therapies adopted in this population, and will explore their relationship with ventricular arrhythmia recurrences and ICD interventions.

Первичные конечные точки

  • Number of participants with ICD-related complications [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (5)
  • Number of ventricular tachyarrhythmia episodes by arrhythmia type [Срок оценки: through study completion, an average of 1 year]
  • Number of ventricular arrhythmia episodes classified by initiation pattern [Срок оценки: through study completion, an average of 1 year]
  • Number of ventricular arrhythmia recurrences [Срок оценки: through study completion, an average of 1 year]
  • Number of ventricular arrhythmia episodes by autonomic pattern [Срок оценки: through study completion, an average of 1 year]
  • Number of appropriate ICD interventions [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Diagnosis of arrhythmogenic cardiomyopathy, including right-dominant arrhythmogenic right ventricular cardiomyopathy, biventricular arrhythmogenic cardiomyopathy, or left-dominant arrhythmogenic left ventricular cardiomyopathy.
  • ICD implantation.
  • Documented sustained ventricular tachyarrhythmia, including polymorphic ventricular tachycardia, ventricular fibrillation, or monomorphic ventricular tachycardia.
  • Periodic clinical and ICD follow-up.
  • Arrhythmia onset available from ICD electrograms and/or ECG recordings.
  • ECG/EGM tracings available for analysis by the steering ECG committee.

Критерии исключения

  • Incomplete ICD data or incomplete ICD follow-up.
  • Significant coronary artery disease, defined as coronary plaque greater than 50% at coronary angiography or coronary computed tomography angiography.
  • Primary valvular heart disease or congenital heart disease.
  • Infiltrative or inflammatory cardiomyopathies, including sarcoidosis or amyloidosis.
  • Previous exposure to therapies associated with cardiac toxicity, including chemotherapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 1. Corrado D, Anastasakis A, Basso C, et al. Proposed diagnostic criteria for arrhythmogenic cardiomyopathy: European Task Force consensus report. Int J Cardiol. 2024;395:131447. doi:10.1016/j.ijcard.2023.131447. 2. Zeppenfeld K, Tfelt-Hansen J, de Riva M, et al. 2022 ESC Guidelines for ventricular arrhythmias and prevention of sudden cardiac death. Eur Heart J. 2022;43:3997-4126. doi:10.1093/eurh

Идентификаторы

NCT: NCT07688200 · TRACE-ACM-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗