Acute Hemodynamic and Biological Effects of ECP and Exercise

Not Applicable

Completed

• Conditions: Patients With Stable Coronary Artery Disease
• Interventions: Other: Hemodynamic and biological measurements

• Registration Number: NCT02014090
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2011-04-05
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Study First Posted: 2013-12-17
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
half supine bicycle Exercise	Hemodynamic and biological measurements	60 minutes of half supine bicycle exercise with submaximal workload
ECP	Hemodynamic and biological measurements	90 minutes of ECP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Puls Wave Velocity Analysis	At baseline & post intervention, expected to be on average 90 minutes

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Bern, Switzerland