Status:
UNKNOWN
A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training.
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Conditions:
Coronary Artery Disease (CAD);
Myocardial Infarction (MI)
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
Cardiac rehabilitation, including physical training, has become accepted treatment following myocardial infarction, coronary stent implantation and coronary bypass operation. Besides modifying patient...
Eligibility Criteria
Inclusion
- patients with CAD (post-PCI, post-MI, post-CABG) and a left ventricular ejection fraction (LVEF) \> 40%
- the presence of CAD is defined as prior angiographically documented stenotic lesion(s) of \> 75%, or documented myocardial infarction (biochemical, ECG, echocardiographic documentation).
- patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
- in practice, patients will have been hospitalized at least 4 weeks prior to participation in the training programme because of PCI, MI or CABG
Exclusion
- significant intercurrent illness last 6 weeks
- known severe ventricular arrhythmia with functional or prognostic significance
- significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
- recent CABG (\< 30 days)
- other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
- co-morbidity that may significantly influence one-year prognosis
- functional or mental disability that may limit exercise
- a habit of regular vigorous exercise or participation in a programme of exercise training less than 3 months before inclusion
- acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
- glomerular filtration rate (GFR) \<25ml/min/1.73m2
- hemoglobin \< 10g/dl
- severe chronic obstructive pulmonary disease
- participation in another clinical trial
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01226225
Start Date
November 1 2010
End Date
September 1 2013
Last Update
November 10 2010
Active Locations (2)
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1
Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
2
Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49
Leuven, Belgium, 3000