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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04111744
Other study ID # PRECAB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2018

Study information

Verified date September 2019
Source Kerckhoff Klinik
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients (pts) with stable coronary artery disease (CAD) requiring coronary artery bypass graft surgery (CABG) may be physically inactive during the waiting period to avoid further risks. Aim of this study is to investigate the feasibility and safety of a preoperative aerobic exercise training in these pts during the waiting period and to analyze its effects on pre-, peri and postoperative outcomes


Description:

Pts with stable coronary artery disease (CAD) and indication for elective CABG will be prospectively randomized into a preoperative training group (TG) or a non active control group (CG). Pts in TG have to perform six sessions of aerobic endurance training within two weeks prior to CABG. The following investigations will be performed at baseline, one day before surgery and at the beginning and at the end of cardiac rehabilitation: a maximal symptom limited ergospirometry, assessment of endothelial function (analysing the reactive hyperaemic index (RHI) via a finger-tonometry), assessment of quality of life (QoL) using the MacNew Heart Disease Questionnaire, laboratory testing of ischemic and inflammatory Parameters. Baseline, peri- and postoperative characteristics will be collected.


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date December 31, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria:

- stable Angina

- indication for elective CABG surgery

- functional capacity > 50 watts

- willingness to participate in the study

Exclusion Criteria:

- unstable Angina

- comorbidities precluding performance of aerobic exercise training (e.g. neurological disorders, orthopedic disorders etc)

- functional Status NYHA IV

- relevant ventricular arrhythmias

- hemodynamic significant heart valve disease

- myocarditis

- cardiomyopathies

- left main coronary artery disease > 50%

- peripheral obstructive disease (Fontaine > IIb)

- reduced life expectancy < 12 months

- CABG surgery during the last six months

- participation in another trial

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Preoperative Exercise Training
Patients undergoing CABG and randomized to the Training Group complete six sessions of aerobic endurance training prior CABG surgery
Optimal medical therapy
Standard medication for stable CAD

Locations

Country Name City State
Germany Kerckhoff Klinik Bad Nauheim

Sponsors (1)

Lead Sponsor Collaborator
Kerckhoff Klinik

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiopulmonary fitness Change of maximal Oxygen consumption Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation
Primary Endothelial function Change of Reactive hyperemic index (RHI) Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation
Secondary Length of hospital stay (LoS) Duration of hospital stay in days Within the acute care period
Secondary Length of ventilation Duration of Ventilation in minutes Within the acute care period
Secondary Functional capacity Change of 6-minute walk test Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Arterial stiffness Changes in arterial pulse wave analysis Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Quality of life Questionnaire 1 Changes in MacNew (Heart Disease Health-related Quality of Life-) Questionnaire questionaire Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Quality of life Questionnaire 2 Changes in Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale that generates ordinal data.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Quality of life Questionnaire 3 Changes in Mobility and Self-supply (MOSES) questionnaire Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Ischemic blood marker 1 High Sensitive Troponin (hs-Trop) Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Ischemic blood marker 2 Creatine kinase (CK) U/L Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Ischemic blood marker 3 Creatine Kinase-MB (CK-MB) U/L Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Ischemic blood marker 4 Lactate dehydrogenase (LDH) U/L Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Ischemic blood marker 5 glutamic oxaloacetic transaminase (GOT) U/L Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Ischemic blood marker 6 glutamate pyruvate transaminase (GPT) U/L Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Ischemic blood marker 7 copeptin U/L Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Inflammatory blood marker 1 C-reactive protein (CRP) U/L Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Inflammatory blood marker 2 Leucozytes 10³/µL Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Inflammatory blood marker 3 Interleukine-6 (IL-6) pg/mL Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Number of patients with a Clinical Event Atrial fibrillation documented by electrocardiogram (ECG) Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Number of patients with a Pulmonary clinical event Pleural effusion, pulmonary infection or other pulmonary disorder with Need for treatment Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation
Secondary Number of patients with a Cardiovascular event Revascularization, re-CABG, rehospitalization due to unstable angina, myocardial infarction after 30 days and 12 months
Secondary Number of patients with a Cerebrovascular event TIA, stroke after 30 days and 12 months
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