TIMELY-PrädiktoR Prospective Study

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Cardiorespiratory Fitness (CRF) — Baseline, week 3, week 24, and week 48
  CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry
• Change in risk of mortality — Baseline, week 3, week 24, and week 48
  Risk of mortality will be determined using the validated biomarker risk score COROPREDICT
• Number of patients with major adverse cardiac and cerebrovascular events (MACCE) — Baseline to week 48, and week 432
  Number of patients with death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization, and major bleeding

Trial sites (1)

Other trials for the same condition