Acute Hemodynamic and Biological Effects of ECP and Exercise

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Patients With Stable Coronary Artery Disease

Treatments: Other: Hemodynamic and biological measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT02014090

177/07

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

half supine bicycle Exercise

Active Comparator group

Description:

60 minutes of half supine bicycle exercise with submaximal workload

Treatment:

Other: Hemodynamic and biological measurements

ECP

Active Comparator group

Description:

90 minutes of ECP

Treatment:

Other: Hemodynamic and biological measurements