Acute Hemodynamic and Biological Effects of ECP and Exercise

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02014090

Enrollment

Registered

2013-12-17

Start date

2008-03-31

Completion date

2011-10-31

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Stable Coronary Artery Disease

Keywords

ECP, Endurance exercise, myocardial perfusion

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.

Interventions

OTHERHemodynamic and biological measurements

by MCE, PWA, Doppler, Multiplex, FACS

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026