TIMELY-PrädiktoR Prospective Study

NCT05461729 | Recruiting

• 1 other identifier: TIMELY_P01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.

Conditions

Coronary Artery Disease

Keywords

Cardiac Rehabilitation; Telemedicine; Healthy Lifestyle; Preventive Programs; Artificial Intelligence; Predictive Medicine; Continuum of Care; Maintenance; Aftercare; eHealth; mHealth

Outcome Measures

Primary Outcomes (3)

• Change in Cardiorespiratory Fitness (CRF)

  CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry

  Baseline, week 3, week 24, and week 48

• Change in risk of mortality

  Risk of mortality will be determined using the validated biomarker risk score COROPREDICT

  Baseline, week 3, week 24, and week 48

• Number of patients with major adverse cardiac and cerebrovascular events (MACCE)

  Number of patients with death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization, and major bleeding

  Baseline to week 48, and week 432

Secondary Outcomes (36)

• Physical activity (PA)

  Baseline, week 3, week 24, and week 48

• Daily step count

  Baseline to week 24

• Weekly number and duration of physical activities

  Baseline to week 24

• Resting heart rate

  Baseline to week 24

• Sleep duration

  Baseline to week 24

Other Outcomes (1)

• Needs and requirements for eHealth in cardiac rehabilitation

  Week 3

Study Arms (1)

Coronary Artery Disease

Patients with Coronary Artery Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Coronary Artery Disease (CAD) patients participating in phase II Cardiac Rehabilitation (CR).

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Boris Schmitz: lead
• European Commission: collaborator
• University of Amsterdam: collaborator
• Technische Universität Dresden: collaborator
• MEDIZINISCHE UNIVERSITAT GRAZ: collaborator
• Stichting Katholieke Universiteit: collaborator
• Foundation for Research and Technology - Hellas: collaborator

Study Sites (1)

Klinik Königsfeld

Ennepetal, North Rhine-Westphalia, 58256, Germany

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous Blood

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Boris Schmitz, PhD

  University of Witten/Herdecke, Dpt. Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Schmitz, PhD

CONTACT

004923339888156; boris.schmitz@uni-wh.de

Frank C. Mooren, MD

CONTACT

004923339888100; Frank.mooren@uni-wh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Researcher Department of Rehabilitation Sciences

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 18, 2022
• Study Start: June 1, 2021
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)