Percutaneous Coronary Intervention (PCI) Clinical Trial
— SAINTEX-CAD
Cardiac rehabilitation, including physical training, has become accepted treatment following
myocardial infarction, coronary stent implantation and coronary bypass operation. Besides
modifying patients' risk profile for future coronary problems, the focus is on improving
exercise capacity. The ability to be able to perform at a higher maximal level is a strong
predictor for outcome (new cardiovascular events and mortality). The main purpose of this
study is to evaluate whether aerobic interval training outweighs more classical moderate
endurance training in improving exercise capacity. During interval training, patients
perform exercise at high intensity, but for only a couple of minutes and then recover at a
lower intensity. Such intervals are repeated. Preliminary evidence from smaller studies
suggests that this type of training leads to a larger increase in exercise capacity,
compared to the more traditional endurance training at moderate intensity.
In addition, mechanisms that might explain how this improvement is achieved, as well as
safety and impact on quality of life will be studied.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen | Edegem | |
Belgium | Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49 | Leuven |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Katholieke Universiteit Leuven, Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing | Comparison of evolution of maximal aerobic capacity from baseline to 6 weeks | 6 weeks | No |
Primary | Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing | Comparison of evolution of maximal aerobic capacity from baseline to 12 weeks | 12 weeks | No |
Primary | Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing | Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing | 12 months | No |
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