Меню
Идёт набор NCT05461729

TIMELY-PrädiktoR Prospective Study

— Наблюдательное Coronary Artery Disease

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: Coronary Artery Disease. 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
Германия
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 →

Обзор

Brief Summary: Cardiac rehabilitation (CR) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (CAD), manage symptoms, and reduce the risk of future cardiovascular events. CR is a structured program not only addressing CAD but also comorbidities including hypertension, dyslipidemia, diabetes and obesity as well as other risk factors. CR aims at long-term lifestyle changes to reduce modifiable risk factors, and it's success depends on a large number of interacting variables including biological, psychological and social factors. Recently, the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood. The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR. Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data, (central) blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge. Follow-up assessments will be performed at least at 6 months and at 12 months after discharge. Events (MACCE) will be collected for up to 10 years. After 2023, the study will be run under the acronym PrädiktoR. Main objectives of the study: 1. To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes. 2. To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD, also to be used in machine learning models and for the generation of digital twins. 3. To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.

Первичные конечные точки

  • Change in Cardiorespiratory Fitness (CRF) [Срок оценки: Baseline, week 3, week 24, and week 48]
  • Change in risk of mortality [Срок оценки: Baseline, week 3, week 24, and week 48]
  • Number of patients with major adverse cardiac and cerebrovascular events (MACCE) [Срок оценки: Baseline to week 48, and week 432]
Вторичные конечные точки (12)
  • Physical activity (PA) [Срок оценки: Baseline, week 3, week 24, and week 48]
  • Daily step count [Срок оценки: Baseline to week 24]
  • Weekly number and duration of physical activities [Срок оценки: Baseline to week 24]
  • Resting heart rate [Срок оценки: Baseline to week 24]
  • Sleep duration [Срок оценки: Baseline to week 24]
  • Physiological stress [Срок оценки: Baseline to week 24]
  • Blood pressure [Срок оценки: Baseline to week 24]
  • Arterial pressure wave propagation/reflection characteristics [Срок оценки: Baseline to week 24]
  • Cardiac arrhythmia [Срок оценки: Baseline to week 24]
  • Body composition [Срок оценки: Baseline, week 3, and week 24, and week 48]
  • Muscle strength [Срок оценки: Baseline, week 3, and week 24]
  • Muscle function [Срок оценки: Baseline, week 3, and week 24, and week 48]

Критерии участия

Критерии включения

Coronary Artery Disease (CAD) patients after myocardial infarction (STEMI/NSTEMI) and/or angioplasty and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery bypass graft surgery who participate in phase II Cardiac Rehabilitation (CR).

Критерии исключения

  • Incapability to give informed consent
  • Conditions that prevent patients from participation in CR including unstable coronary or cerebrovascular conditions and acute infections

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Klinik Königsfeld — Ennepetal

Публикации

  • Schmitz B, Wirtz S, Sestayo-Fernandez M, Schafer H, Douma ER, Alonso Vazquez M, Gonzalez-Salvado V, Habibovic M, Gatsios D, Kop WJ, Pena-Gil C, Mooren F. Living Lab Data of Patient Needs and Expectations for eHealth-Based Cardiac Rehabilitation in Germany and Spain From the TIMELY Study: Cross-Sectional Analysis. J Med Internet Res. 2024 Feb 22;26:e53991. doi: 10.2196/53991. PMID 38386376

Идентификаторы

NCT: NCT05461729 · TIMELY_P01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗