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NCT Number: NCT05461729

TIMELY-PrädiktoR Prospective Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik Königsfeld

Ennepetal, North Rhine-Westphalia, 58256, Germany

Location status: Recruiting

Location contact

Boris Schmitz, PhD

PRINCIPAL_INVESTIGATOR

Frank C Mooren, MD

CONTACT

[email protected]

004923339888100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Cardiorespiratory Fitness (CRF)

    Time frame: Baseline, week 3, week 24, and week 48

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

  2. Change in risk of mortality

    Time frame: Baseline, week 3, week 24, and week 48

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

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

    Time frame: Baseline to week 48, and week 432

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

Secondary outcomes

  1. Physical activity (PA)

    Time frame: Baseline, week 3, week 24, and week 48

    PA will be measured by validated BSA questionnaire (Bewegungs- und Sportaktivität) and expressed as metabolic equivalents

  2. Daily step count

    Time frame: Baseline to week 24

    Steps will be measured using electronic devices such as wrist-worn activity trackers

  3. Weekly number and duration of physical activities

    Time frame: Baseline to week 24

    Number and duration of physical activities will be measured using electronic devices such as wrist-worn activity trackers

  4. Resting heart rate

    Time frame: Baseline to week 24

    Resting heart rate will be measured using electronic devices such as wrist-worn activity trackers

  5. Sleep duration

    Time frame: Baseline to week 24

    Sleep duration will be measured using electronic devices such as wrist-worn activity trackers

  6. Physiological stress

    Time frame: Baseline to week 24

    Physiological stress will be measured using electronic devices such as wrist-worn activity trackers

  7. Blood pressure

    Time frame: Baseline to week 24

    Central and peripheral systolic and diastolic blood pressure will be measured using automatic upper-arm sphygmomanometers. Data transmitted by telemetry.

  8. Arterial pressure wave propagation/reflection characteristics

    Time frame: Baseline to week 24

    Arterial pressure wave propagation/reflection characteristics will be measured using automatic upper-arm tonometry. Data transmitted by telemetry.

  9. Cardiac arrhythmia

    Time frame: Baseline to week 24

    Cardiac arrhythmia will be measured using three-channel Holter ECG.

  10. Body composition

    Time frame: Baseline, week 3, and week 24, and week 48

    Body composition including fat mass, muscle mass, and visceral fat area will be measured by bioimpedance analysis.

  11. Muscle strength

    Time frame: Baseline, week 3, and week 24

    Arm and leg extension and flexion strength will be measured using Isokinetic devices

  12. Muscle function

    Time frame: Baseline, week 3, and week 24, and week 48

    Muscle function will be measured by 30-second chair rise test

  13. Submaximal exercise capacity

    Time frame: Baseline, week 3, and week 24, and week 48

    Submaximal exercise capacity will be measured using 6-min walking test

  14. Habit formation

    Time frame: Baseline, week 3, week 24, and week 48

    Habit formation will be assessed using validated questionnaire for the "Self-Report Behavioural Automaticity Index (SRBAI)".

  15. Nicotine dependence

    Time frame: Baseline, week 3, week 24, and week 48

    Nicotine dependence will be assessed using the Fagerström questionnaire

  16. Cardiac Self-Efficacy

    Time frame: Baseline, week 3, week 24, and week 48

    Cardiac Self-Efficacy will be assessed using the validated "Cardiac Self-Efficacy Scale (CSE)"

  17. Impact of disease

    Time frame: Baseline, week 3, week 24, and week 48

    Impact of disease will be assessed using the "brief illness perception (IPQ-9)" questionnaire .

  18. General wellbeing

    Time frame: Baseline, week 3, week 24, and week 48

    General wellbeing will be assessed using the "Positive And Negative Affect Scale (PANAS)" questionnaire .

  19. Fear of Activity/ Kinesiophobia

    Time frame: Baseline, week 3, week 24, and week 48

    Fear of Activity/ Kinesiophobia will be assessed using the modified "Fear of Activity Scale (FActS)".

  20. Depression

    Time frame: Baseline, week 3, week 24, and week 48

    Depression will be assessed using the modified "Patient Health Questionnaire (PHQ-9)".

  21. General anxiety

    Time frame: Baseline, week 3, week 24, and week 48

    General anxiety will be assessed using the "7-item General Anxiety Scale (GAD-7)".

  22. Health-related quality of life

    Time frame: Baseline, week 3, week 24, and week 48

    Health-related quality of life will be assessed using the "RAND 36-Item Health Survey (SF-36)".

  23. General quality of life

    Time frame: Baseline, week 3, week 24, and week 48

    Quality of life will be assessed using the "5-level EQ-5D (EQ-5D-5L) health status measure".

  24. Wellbeing

    Time frame: Baseline, week 3, week 24, and week 48

    Wellbeing will be assessed using the "WHO-5 Well-Being Index".

  25. Perceived stress

    Time frame: Baseline, week 3, week 24, and week 48

    Perceived stress will be assessed using the "Perceived Stress Scale (PSS-4)".

  26. Optimism/ Pessimism

    Time frame: Baseline, week 3, week 24, and week 48

    Optimism/ Pessimism will be assessed using the modified "Life Orientation Test (LOT-R)".

  27. Conscientiousness

    Time frame: Baseline, week 3, week 24, and week 48

    Conscientiousness will be assessed using the "The Big Five Inventor (BFI-10)".

  28. Psychological flexibility

    Time frame: Baseline, week 3, week 24, and week 48

    Psychological flexibility will be assessed using the psychometric properties of the "Acceptance and Action Questionnaire-I (AAQ-II)".

  29. Negative Affectivity

    Time frame: Baseline, week 3, week 24, and week 48

    Standard assessment of negative affectivity, social inhibition, and Type D personality (DS-14)

  30. Trait anger

    Time frame: Baseline, week 3, week 24, and week 48

    Trait anger will be assessed using the "State-Trait Anger Expression Inventory-2 ("TAI-10/STAXI-2").

  31. Religiousness/ spirituality

    Time frame: Baseline, week 3, week 24, and week 48

    Religiousness/ spirituality will be assessed using the "Spiritual and Religious Attitudes in Dealing with Illness (GrAw-7/ SpREUK-15)" questionnaire.

  32. Fatigue

    Time frame: Baseline, week 3, week 24, and week 48

    Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".

  33. Psychological situation in the working environment

    Time frame: Baseline, week 3, week 24, and week 48

    Psychological situation in the working environment will be assessed using the "The effort-reward imbalance model (ERI10+6)".

  34. Work requirements and workload

    Time frame: Baseline, week 3, week 24, and week 48

    Work requirements and workload will be assessed using the "Workability Index (WAI)".

  35. Social support

    Time frame: Baseline, week 3, week 24, and week 48

    Social support will be assessed using the short "Perceived Social Support Questionnaire (F-SozU K6)".

  36. Relationship satisfaction

    Time frame: Baseline, week 3, week 24, and week 48

    Relationship satisfaction will be assessed using the "Quality of Marriage Index (QMI)".

Other outcomes

  1. Needs and requirements for eHealth in cardiac rehabilitation

    Time frame: Week 3

    Needs and requirements for eHealth in cardiac rehabilitation will be assessed using questionnaires, interviews, and focus groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Boris Schmitz, PhD

CONTACT

[email protected]

004923339888156

Frank C. Mooren, MD

CONTACT

[email protected]

004923339888100

Sponsors and collaborators

Lead sponsor

Dr. Boris Schmitz

Other

Collaborators

  • European Commission
  • Foundation for Research and Technology - Hellas
  • MEDIZINISCHE UNIVERSITAT GRAZ
  • Stichting Katholieke Universiteit
  • Technische Universität Dresden
  • University of Amsterdam

Registry information

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Jul 18, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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