Acute Hemodynamic and Biological Effects of ECP and Exercise

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals

Conditions
-----------------
Patients With Stable Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Hemodynamic and biological measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, written informed consent to participate in the study Exclusion Criteria: 1. Pregnancy (serum β-HCG<2 IU/l for all female volunteers) Baseline History: Endurance exercise 5 days before and the days between the exams History of cardiovascular disease or surgery, including arterial hypertension, Raynaud phenomenon, recurrent migraine, or any cardiac rhythm disorder History of metabolic disorder, particularly diabetes mellitus History of respiratory, renal, hepatic or cerebral disease Allergic reactions to Luminity or its components Cardiovascular medication Illness characterized by acute phase response Anaemia with haemoglobin levels < 110 g/L Baseline Physical Examination: 1. Peripheral artery disease Baseline Echocardiogram: Valvular heart disease Aortic aneurysm (any abnormality of ascending aorta, aortic arch or descending aorta) Intra- or extracardiac shunt Systolic or diastolic left ventricular (LV) dysfunction LV-hypertrophy Pulmonary arterial hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: half supine bicycle Exercise<br>60 minutes of half supine bicycle exercise with submaximal workload | Other: Hemodynamic and biological measurements<br>* by MCE, PWA, Doppler, Multiplex, FACS<br>|
| Active Comparator: ECP<br>90 minutes of ECP | Other: Hemodynamic and biological measurements<br>* by MCE, PWA, Doppler, Multiplex, FACS<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE) |  | During ECP respectively Bicycle Exercise, expected to be on average 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puls Wave Velocity Analysis |  | At baseline & post intervention, expected to be on average 90 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECP, Endurance exercise, myocardial perfusion