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Acute Hemodynamic and Biological Effects of ECP and Exercise

NCT ID: NCT02014090

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Patients With Stable Coronary Artery Disease

Keywords

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ECP Endurance exercise myocardial perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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half supine bicycle Exercise

60 minutes of half supine bicycle exercise with submaximal workload

Group Type ACTIVE_COMPARATOR

Hemodynamic and biological measurements

Intervention Type OTHER

by MCE, PWA, Doppler, Multiplex, FACS

ECP

90 minutes of ECP

Group Type ACTIVE_COMPARATOR

Hemodynamic and biological measurements

Intervention Type OTHER

by MCE, PWA, Doppler, Multiplex, FACS

Interventions

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Hemodynamic and biological measurements

by MCE, PWA, Doppler, Multiplex, FACS

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Christian Seiler

Prof Dr med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steffen Gloekler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Stefano de Marchi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Stefano Rimoldi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Christian Seiler, MD

Role: STUDY_DIRECTOR

University of Bern

Locations

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University Hospital

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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177/07

Identifier Type: -

Identifier Source: org_study_id