| NCT ID | NCT05461729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Boris Schmitz |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2021-06-01 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 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
Contact & Investigator
Boris Schmitz, PhD
PRINCIPAL INVESTIGATOR
University of Witten/Herdecke, Dpt. Rehabilitation Sciences
Frequently Asked Questions
Who can join the NCT05461729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05461729 currently recruiting?
Yes, NCT05461729 is actively recruiting participants. Contact the research team at boris.schmitz@uni-wh.de for enrollment information.
Where is the NCT05461729 trial being conducted?
This trial is being conducted at Ennepetal, Germany.
Who is sponsoring the NCT05461729 clinical trial?
NCT05461729 is sponsored by Dr. Boris Schmitz. The principal investigator is Boris Schmitz, PhD at University of Witten/Herdecke, Dpt. Rehabilitation Sciences. The trial plans to enroll 1,200 participants.