TIMELY Prospective Study

Coronary Artery Disease Clinical Trial

— TIMELY  

Official title:

TIMELY Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05461729
• Other study ID #: TIMELY_P01
• Status: Active, not recruiting
• Start date: June 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 612
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Germany	Klinik Königsfeld	Ennepetal	NRW

Sponsors (7)

Lead Sponsor	Collaborator
Dr. Boris Schmitz	European Commission, Foundation for Research and Technology - Hellas, MEDIZINISCHE UNIVERSITAT GRAZ, Stichting Katholieke Universiteit, Technische Universität Dresden, University of Amsterdam

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Needs and requirements for eHealth in cardiac rehabilitation	Needs and requirements for eHealth in cardiac rehabilitation will be assessed using questionnaires, interviews, and focus groups.	Week 3
Primary	Change in Cardiorespiratory Fitness (CRF)	CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry	Baseline, week 3, and week 24
Primary	Change in risk of mortality	Risk of mortality will be determined using the validated biomarker risk score COROPREDICT	Baseline, week 3, and week 24
Primary	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
Secondary	Physical activity (PA)	PA will be measured by validated BSA questionnaire (Bewegungs- und Sportaktivität) and expressed as metabolic equivalents	Baseline, week 3, week 24, and week 48
Secondary	Daily step count	Steps will be measured using electronic devices such as wrist-worn activity trackers	Baseline to week 24
Secondary	Weekly number and duration of physical activities	Number and duration of physical activities will be measured using electronic devices such as wrist-worn activity trackers	Baseline to week 24
Secondary	Resting heart rate	Resting heart rate will be measured using electronic devices such as wrist-worn activity trackers	Baseline to week 24
Secondary	Sleep duration	Sleep duration will be measured using electronic devices such as wrist-worn activity trackers	Baseline to week 24
Secondary	Physiological stress	Physiological stress will be measured using electronic devices such as wrist-worn activity trackers	Baseline to week 24
Secondary	Blood pressure	Central and peripheral systolic and diastolic blood pressure will be measured using automatic upper-arm sphygmomanometers. Data transmitted by telemetry.	Baseline to week 24
Secondary	Arterial pressure wave propagation/reflection characteristics	Arterial pressure wave propagation/reflection characteristics will be measured using automatic upper-arm tonometry. Data transmitted by telemetry.	Baseline to week 24
Secondary	Cardiac arrhythmia	Cardiac arrhythmia will be measured using three-channel Holter ECG.	Baseline to week 24
Secondary	Body composition	Body composition including fat mass, muscle mass, and visceral fat area will be measured by bioimpedance analysis.	Baseline, week 3, and week 24
Secondary	Muscle strength	Arm and leg extension and flexion strength will be measured using Isokinetic devices	Baseline, week 3, and week 24
Secondary	Muscle function	Muscle function will be measured by 30-second chair rise test	Baseline, week 3, and week 24
Secondary	Submaximal exercise capacity	Submaximal exercise capacity will be measured using 6-min walking test	Baseline, week 3, and week 24
Secondary	Habit formation	Habit formation will be assessed using validated questionnaire for the "Self-Report Behavioural Automaticity Index (SRBAI)".	Baseline, week 3, week 24, and week 48
Secondary	Nicotine dependence	Nicotine dependence will be assessed using the Fagerström questionnaire	Baseline, week 3, week 24, and week 48
Secondary	Cardiac Self-Efficacy	Cardiac Self-Efficacy will be assessed using the validated "Cardiac Self-Efficacy Scale (CSE)"	Baseline, week 3, week 24, and week 48
Secondary	Impact of disease	Impact of disease will be assessed using the "brief illness perception (IPQ-9)" questionnaire .	Baseline, week 3, week 24, and week 48
Secondary	General wellbeing	General wellbeing will be assessed using the "Positive And Negative Affect Scale (PANAS)" questionnaire .	Baseline, week 3, week 24, and week 48
Secondary	Fear of Activity/ Kinesiophobia	Fear of Activity/ Kinesiophobia will be assessed using the modified "Fear of Activity Scale (FActS)".	Baseline, week 3, week 24, and week 48
Secondary	Depression	Depression will be assessed using the modified "Patient Health Questionnaire (PHQ-9)".	Baseline, week 3, week 24, and week 48
Secondary	General anxiety	General anxiety will be assessed using the "7-item General Anxiety Scale (GAD-7)".	Baseline, week 3, week 24, and week 48
Secondary	Health-related quality of life	Health-related quality of life will be assessed using the "RAND 36-Item Health Survey (SF-36)".	Baseline, week 3, week 24, and week 48
Secondary	General quality of life	Quality of life will be assessed using the "5-level EQ-5D (EQ-5D-5L) health status measure".	Baseline, week 3, week 24, and week 48
Secondary	Wellbeing	Wellbeing will be assessed using the "WHO-5 Well-Being Index".	Baseline, week 3, week 24, and week 48
Secondary	Perceived stress	Perceived stress will be assessed using the "Perceived Stress Scale (PSS-4)".	Baseline, week 3, week 24, and week 48
Secondary	Optimism/ Pessimism	Optimism/ Pessimism will be assessed using the modified "Life Orientation Test (LOT-R)".	Baseline, week 3, week 24, and week 48
Secondary	Conscientiousness	Conscientiousness will be assessed using the "The Big Five Inventor (BFI-10)".	Baseline, week 3, week 24, and week 48
Secondary	Psychological flexibility	Psychological flexibility will be assessed using the psychometric properties of the "Acceptance and Action Questionnaire-I (AAQ-II)".	Baseline, week 3, week 24, and week 48
Secondary	Negative Affectivity	Standard assessment of negative affectivity, social inhibition, and Type D personality (DS-14)	Baseline, week 3, week 24, and week 48
Secondary	Trait anger	Trait anger will be assessed using the "State-Trait Anger Expression Inventory-2 ("TAI-10/STAXI-2").	Baseline, week 3, week 24, and week 48
Secondary	Religiousness/ spirituality	Religiousness/ spirituality will be assessed using the "Spiritual and Religious Attitudes in Dealing with Illness (GrAw-7/ SpREUK-15)" questionnaire.	Baseline, week 3, week 24, and week 48
Secondary	Fatigue	Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".	Baseline, week 3, week 24, and week 48
Secondary	Psychological situation in the working environment	Psychological situation in the working environment will be assessed using the "The effort-reward imbalance model (ERI10+6)".	Baseline, week 3, week 24, and week 48
Secondary	Work requirements and workload	Work requirements and workload will be assessed using the "Workability Index (WAI)".	Baseline, week 3, week 24, and week 48
Secondary	Social support	Social support will be assessed using the short "Perceived Social Support Questionnaire (F-SozU K6)".	Baseline, week 3, week 24, and week 48
Secondary	Relationship satisfaction	Relationship satisfaction will be assessed using the "Quality of Marriage Index (QMI)".	Baseline, week 3, week 24, and week 48