Coronary artery disease/arteriogenesis/endothelial function Circulatory System Coronary artery disease
Conditions
Interventions
Current information as of 20/10/2008:
The EECP course consists of 35 1-hour sessions of therapy over 7 weeks. The therapy takes place in outpatient clinics. Patients in the control group visit the out
Sponsors
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both genders 2. Age greater than 30 to less than 80 years 3. Suffering from stable coronary vessel disease for more than 3 months 4. With an angiographically diagnosed haemodynamic significant stenosis of at least one epicardial vessel 5. An objective positive test for stress-induced ischaemic imaging and pathological Fractional Flow Reserve (FFR less than 0.8)
Exclusion criteria
Exclusion criteria: 1. Unstable angina 2. After aorto-coronary bypass grafting 3. No previous Q-wave infarction in the area assessed for coronary collaterals 4. Non-ischaemic left ventricle dysfunction Ejection Fraction (EF) less than 35%, fluid overload 5. Tricuspid and aortic valve insufficiency greater than grade II and aortic valve stenosis greater than grade II 6. Relevant stenosis of the aorta abdominalis or aorta thoracica, coarctatio aortae 7. Symptomatic angiopathy of the lower limb (neuropathy, vasculitis, symptomatic Peripheral Arterial Disease [PAD] ankle pressure less than 80 mmHg) 8. Chronic venous insufficiency grade greater than III, symptomatic varicosis, thrombosis, occlusion of vena cava inferior, phlebitis 9. Evident lesions at the lower extremity (ulcera, big scar, etc.) 10. Diabetic retinopathy 11. Anticoagulation International Normalised Ratio (INR) greater than 3 or less and bleeding symptoms, disturbed homeostasis 12. Orthopaedic disease (hip, knee) 13. Severe systemic disease 14. Severe hypertension greater than 180 mmHg 15. Status post cerebral bleeding 16. Pregnancy 17. Mental retardation or dementia 18. Severe kinking of coronary vessels 19. Atrial fibrillation 20. Pacemaker (PM)/Implantable Cardioverter Defibrillator (ICD), metal valve 21. Acute renal insufficiency, progressive renal insufficiency, chronic renal insufficiency - cut off creatinine 2 mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in CFIp and FFR indexes evaluated at baseline and after the 7 weeks therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in CMR perfusion at rest and under adenosine. Quantitative assessment (ml/min/g of myocardium) 2. Changes in the Ejection Fraction (EF) assessed through CMR and echocardiography 3. Changes in the Canadian Cardiovascular Society (CCS) classification of the angina pectoris and in the New York Heart Association (NYHA) classification of the heart failure 4. Treadmill test for ischaemic signs 5. Changes in the plasma levels of pro-arteriogenic and pro-angiogenic markers 6. Changes in the plasma levels of several markers of the endothelial function The endpoints 1, 2, 3, 5, 6 are evaluated at baseline, after 2 weeks of therapy, after 7 weeks (end of EECP) and 6 months after the therapy. Point 4 is assessed at baseline and after 7 weeks. | — |
Countries
Germany
Outcome results
None listed