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TIMELY-PrädiktoR Prospective Study

NCT05461729 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2026-03-30

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • University of Amsterdam

    collaborator OTHER

  • Technische Universität Dresden

    collaborator OTHER

  • MEDIZINISCHE UNIVERSITAT GRAZ

    collaborator UNKNOWN

  • Stichting Katholieke Universiteit

    collaborator OTHER

  • Foundation for Research and Technology - Hellas

    collaborator UNKNOWN

  • Dr. Boris Schmitz

    lead OTHER

Principal Investigators

  • Boris Schmitz, PhD · University of Witten/Herdecke, Dpt. Rehabilitation Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2029-08-31
Completion
2029-08-31

Countries

  • Germany

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05461729 on ClinicalTrials.gov