Coronary Artery Disease
Conditions
Keywords
Cardiac Rehabilitation, Telemedicine, Healthy Lifestyle, Preventive Programs, Artificial Intelligence, Predictive Medicine, Continuum of Care, Maintenance, Aftercare, eHealth, mHealth
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.
Interventions
None listed
Sponsors
Dr. Boris Schmitz
European Commission
University of Amsterdam
Technische Universität Dresden
MEDIZINISCHE UNIVERSITAT GRAZ
Stichting Katholieke Universiteit
Foundation for Research and Technology - Hellas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiorespiratory Fitness (CRF) | Baseline, week 3, week 24, and week 48 | CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry |
| Change in risk of mortality | Baseline, week 3, week 24, and week 48 | Risk of mortality will be determined using the validated biomarker risk score COROPREDICT |
| Number of patients with major adverse cardiac and cerebrovascular events (MACCE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical activity (PA) | Baseline, week 3, week 24, and week 48 | PA will be measured by validated BSA questionnaire (Bewegungs- und Sportaktivität) and expressed as metabolic equivalents |
| Daily step count | Baseline to week 24 | Steps will be measured using electronic devices such as wrist-worn activity trackers |
| Weekly number and duration of physical activities | Baseline to week 24 | Number and duration of physical activities will be measured using electronic devices such as wrist-worn activity trackers |
| Resting heart rate | Baseline to week 24 | Resting heart rate will be measured using electronic devices such as wrist-worn activity trackers |
| Sleep duration | Baseline to week 24 | Sleep duration will be measured using electronic devices such as wrist-worn activity trackers |
| Physiological stress | Baseline to week 24 | Physiological stress will be measured using electronic devices such as wrist-worn activity trackers |
| Blood pressure | Baseline to week 24 | Central and peripheral systolic and diastolic blood pressure will be measured using automatic upper-arm sphygmomanometers. Data transmitted by telemetry. |
| Arterial pressure wave propagation/reflection characteristics | Baseline to week 24 | Arterial pressure wave propagation/reflection characteristics will be measured using automatic upper-arm tonometry. Data transmitted by telemetry. |
| Cardiac arrhythmia | Baseline to week 24 | Cardiac arrhythmia will be measured using three-channel Holter ECG. |
| Body composition | 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. |
| Muscle strength | Baseline, week 3, and week 24 | Arm and leg extension and flexion strength will be measured using Isokinetic devices |
| Muscle function | Baseline, week 3, and week 24, and week 48 | Muscle function will be measured by 30-second chair rise test |
| Submaximal exercise capacity | Baseline, week 3, and week 24, and week 48 | Submaximal exercise capacity will be measured using 6-min walking test |
| Habit formation | Baseline, week 3, week 24, and week 48 | Habit formation will be assessed using validated questionnaire for the "Self-Report Behavioural Automaticity Index (SRBAI)". |
| Nicotine dependence | Baseline, week 3, week 24, and week 48 | Nicotine dependence will be assessed using the Fagerström questionnaire |
| Cardiac Self-Efficacy | Baseline, week 3, week 24, and week 48 | Cardiac Self-Efficacy will be assessed using the validated "Cardiac Self-Efficacy Scale (CSE)" |
| Impact of disease | Baseline, week 3, week 24, and week 48 | Impact of disease will be assessed using the "brief illness perception (IPQ-9)" questionnaire . |
| General wellbeing | Baseline, week 3, week 24, and week 48 | General wellbeing will be assessed using the "Positive And Negative Affect Scale (PANAS)" questionnaire . |
| Fear of Activity/ Kinesiophobia | Baseline, week 3, week 24, and week 48 | Fear of Activity/ Kinesiophobia will be assessed using the modified "Fear of Activity Scale (FActS)". |
| Depression | Baseline, week 3, week 24, and week 48 | Depression will be assessed using the modified "Patient Health Questionnaire (PHQ-9)". |
| General anxiety | Baseline, week 3, week 24, and week 48 | General anxiety will be assessed using the "7-item General Anxiety Scale (GAD-7)". |
| Health-related quality of life | 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)". |
| General quality of life | 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". |
| Wellbeing | Baseline, week 3, week 24, and week 48 | Wellbeing will be assessed using the "WHO-5 Well-Being Index". |
| Perceived stress | Baseline, week 3, week 24, and week 48 | Perceived stress will be assessed using the "Perceived Stress Scale (PSS-4)". |
| Optimism/ Pessimism | Baseline, week 3, week 24, and week 48 | Optimism/ Pessimism will be assessed using the modified "Life Orientation Test (LOT-R)". |
| Conscientiousness | Baseline, week 3, week 24, and week 48 | Conscientiousness will be assessed using the "The Big Five Inventor (BFI-10)". |
| Psychological flexibility | 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)". |
| Negative Affectivity | Baseline, week 3, week 24, and week 48 | Standard assessment of negative affectivity, social inhibition, and Type D personality (DS-14) |
| Trait anger | 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"). |
| Religiousness/ spirituality | 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. |
| Fatigue | Baseline, week 3, week 24, and week 48 | Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)". |
| Psychological situation in the working environment | 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)". |
| Work requirements and workload | Baseline, week 3, week 24, and week 48 | Work requirements and workload will be assessed using the "Workability Index (WAI)". |
| Social support | Baseline, week 3, week 24, and week 48 | Social support will be assessed using the short "Perceived Social Support Questionnaire (F-SozU K6)". |
| Relationship satisfaction | Baseline, week 3, week 24, and week 48 | Relationship satisfaction will be assessed using the "Quality of Marriage Index (QMI)". |
Countries
Germany
Contacts
CONTACTBoris Schmitz, PhD
CONTACTFrank C. Mooren, MD
PRINCIPAL_INVESTIGATORBoris Schmitz, PhD
University of Witten/Herdecke, Dpt. Rehabilitation Sciences
Outcome results
None listed