Impact of EECP-treatment (Enhanced External Counterpulsation) on myocardial adaptive arteriogenesis in patients suffering from stable symptomatic coronary heart disease

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 21

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in CFIp and FFR indexes evaluated at baseline and after the 7 weeks therapy.

Secondary Outcome Measures

Name	Time	Method
1. Changes in CMR perfusion at rest and under adenosine. Quantitative assessment (ml/min/g of myocardium)<br>2. Changes in the Ejection Fraction (EF) assessed through CMR and echocardiography<br>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<br>4. Treadmill test for ischaemic signs<br>5. Changes in the plasma levels of pro-arteriogenic and pro-angiogenic markers<br>6. Changes in the plasma levels of several markers of the endothelial function<br><br>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.