TIMELY-PrädiktoR Prospective Study

Overview

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.

Primary outcome measures

• Change in Cardiorespiratory Fitness (CRF) [Time frame: Baseline, week 3, week 24, and week 48]
• Change in risk of mortality [Time frame: Baseline, week 3, week 24, and week 48]
• Number of patients with major adverse cardiac and cerebrovascular events (MACCE) [Time frame: Baseline to week 48, and week 432]

Secondary outcome measures (12)

• Physical activity (PA) [Time frame: Baseline, week 3, week 24, and week 48]
• Daily step count [Time frame: Baseline to week 24]
• Weekly number and duration of physical activities [Time frame: Baseline to week 24]
• Resting heart rate [Time frame: Baseline to week 24]
• Sleep duration [Time frame: Baseline to week 24]
• Physiological stress [Time frame: Baseline to week 24]
• Blood pressure [Time frame: Baseline to week 24]
• Arterial pressure wave propagation/reflection characteristics [Time frame: Baseline to week 24]
• Cardiac arrhythmia [Time frame: Baseline to week 24]
• Body composition [Time frame: Baseline, week 3, and week 24, and week 48]
• Muscle strength [Time frame: Baseline, week 3, and week 24]
• Muscle function [Time frame: Baseline, week 3, and week 24, and week 48]

Eligibility criteria

Inclusion criteria

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).

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 1 center

• Klinik Königsfeld — Ennepetal

Publications

• 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

Identifiers

NCT: NCT05461729 · TIMELY_P01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗