TIMELY Prospective Study

Dr. Boris Schmitz

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05461729

TIMELY_P01

Details and patient eligibility

About

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.

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

Enrollment: 612 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

612 participants in 1 patient group

Coronary Artery Disease

Description:

Patients with Coronary Artery Disease