Patients With Stable Coronary Artery Disease Clinical Trial
Official title:
Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals
| Verified date | December 2013 |
| Source | University Hospital Inselspital, Berne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External Counterpulsation (EECP) with regard to coronary collateral growth.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age > 18 years, written informed consent to participate in the study Exclusion Criteria: - 1. Pregnancy (serum ß-HCG<2 IU/l for all female volunteers) Baseline History: 1. Endurance exercise 5 days before and the days between the exams 2. History of cardiovascular disease or surgery, including arterial hypertension, Raynaud phenomenon, recurrent migraine, or any cardiac rhythm disorder 3. History of metabolic disorder, particularly diabetes mellitus 4. History of respiratory, renal, hepatic or cerebral disease 5. Allergic reactions to Luminity or its components 6. Cardiovascular medication 7. Illness characterized by acute phase response 8. Anaemia with haemoglobin levels < 110 g/L Baseline Physical Examination: 1. Peripheral artery disease Baseline Echocardiogram: 1. Valvular heart disease 2. Aortic aneurysm (any abnormality of ascending aorta, aortic arch or descending aorta) 3. Intra- or extracardiac shunt 4. Systolic or diastolic left ventricular (LV) dysfunction 5. LV-hypertrophy 6. Pulmonary arterial hypertension |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital | Bern |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Inselspital, Berne |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE) | During ECP respectively Bicycle Exercise, expected to be on average 90 minutes | No | |
| Secondary | Puls Wave Velocity Analysis | At baseline & post intervention, expected to be on average 90 minutes | No |