The Multicenter Cardiology Monitoring Platform Registry
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: Heart Failure, Cardiomyopathies, Atrial Fibrillation, Ventricular Arrythmia. Базовые параметры: от 16 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
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
The Multicenter Cardiology Monitoring Platform Registry (mCMP-registry)
Обзор
The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is a prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional). It's objective is to optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.
Подробное описание
Rationale: Heart failure (HF) represents a heterogeneous range of clinical overlapping cardiomyopathy phenotypes, resulting from multifactorial environmental insults in the presence or absence of a genetic predisposition. A better understanding of (early) cardiomyopathy phenotypes, related cardiovascular diseases, their underlying pathophysiological processes, and their related disease burden is key to pave the way for novel preventive and/or intervention studies.
Objective: To optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.
Study design: The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is an investigator-initiated multicentre prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional).
Study population: All subjects aged ≥16 years that have been referred to the cardiology or genetics department for cardiac symptoms, cardiac screening or cardiogenetic screening are eligible for inclusion.
Main study parameters/endpoints: This is a prospective registry from which multiple research questions can be answered. In general, two main approaches will be used: (A) a data-driven (multi-)omics approach which aims to identify clusters of patients to predict clinical outcome, to improve (early) diagnosis, and/or to identify clusters of patients that share underlying pathophysiological processes; (B) a hypothesis-driven approach in which clinical parameters are tested for their (incremental) diagnostic and/or prognostic value.
Первичные конечные точки
- (sudden) cardiac death or heart transplantation [Срок оценки: through study completion, an average of 15 years]
Вторичные конечные точки (4)
- Heart Failure hospitalization [Срок оценки: through study completion, an average of 15 years]
- Life-threatening arrhythmias [Срок оценки: through study completion, an average of 15 years]
- Quality of life EQ-5D questionnaire [Срок оценки: through study completion, an average of 15 years]
- Economic burden [Срок оценки: through study completion, an average of 15 years]
Критерии участия
Критерии включения
- Referred to the cardiology or genetic department for heart failure like symptoms (as stated in the ESC 2016 Guidelines(3)) or for cardiac/cardiogenetic screening;
- Age ≥16 years.
Критерии исключения
- Unwillingness to participate or unable to give written informed consent (e.g. due to language barriers or severe intellectual disability).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- Maastricht UMC+ — Maastricht
Публикации
- Henkens MTHM, Weerts J, Verdonschot JAJ, Raafs AG, Stroeks S, Sikking MA, Amin H, Mourmans SGJ, Geraeds CBG, Sanders-van Wijk S, Barandiaran Aizpurua A, Uszko-Lencer NHMK, Krapels IPC, Wolffs PFG, Brunner HG, van Leeuwen REW, Verhesen W, Schalla SM, van Stipdonk AWM, Knackstedt C, Li X, Abdul Hamid MA, van Paassen P, Hazebroek MR, Vernooy K, Brunner-La Rocca HP, van Empel VPM, Heymans SRB. Improvi PMID 35118823
Идентификаторы
NCT: NCT04976348 · NL76585.068.21