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External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

NCT ID: NCT00414297

Last Updated: 2010-10-26

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous coronary intervention (PCI) is to evaluate the efficacy of External Counterpulsation (ECP) with regard to the promotion of coronary collateral growth.

Detailed Description

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Alternative strategies for the promotion of coronary collaterals (arteriogenesis) are a promising therapeutic alternative for at least 20% of all Patients with Coronary Artery Disease (CAD). Beside growth factors, physical exercise has been shown to improve coronary collateral function. Extracorporal Counterpulsation (ECP) mimics physical exercise in a standardized way. Before and after ECP treatment, a quantitative invasive assessment of absolute collateral flow (by calculating the CFI, i.e. Collateral Flow Index) and myocardial perfusion is performed (with calculation of the CPI, i.e. Collateral Perfusion Index and MPR, i.e. Myocardial Perfusion Reserve).

The study setting is single-blinded, sham-controlled and proceptive .

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1 ECP

active ECP Therapy

Group Type ACTIVE_COMPARATOR

ECP Therapy

Intervention Type DEVICE

application of ECP Therapy to CAD Patients

2

Sham ECP Treatment

Group Type PLACEBO_COMPARATOR

ECP Therapy

Intervention Type DEVICE

application of ECP Therapy to CAD Patients

Interventions

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ECP Therapy

application of ECP Therapy to CAD Patients

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years old
* 1- to 3-vessel coronary artery disease (CAD)
* Stable angina pectoris
* At least 1 stenotic lesion suitable for PCI within the next 4 weeks
* No Q-wave myocardial infarction in the area undergoing CFI measurement
* Written informed consent to participate in the study

Exclusion Criteria

* Patients admitted as emergencies
* Acute myocardial infarction within the last 3 months
* Unstable CAD
* CAD treated best by CABG
* Coronary stenotic lesion to be treated ad-hoc or within \< 4 weeks
* Severe valve disease
* Pulmonary artery hypertension
* Congestive heart failure
* Atrial fibrillation
* Thrombophlebitis and/or deep vein thrombosis
* Occlusive peripheral artery disease
* Abdominal aortic aneurysm
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Cardiology

Principal Investigators

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Christian Seiler, MD, Prof.

Role: STUDY_CHAIR

University of Bern

Steffen Gloekler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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Bern University Hospital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Al Kaabi A, Traupe T, Stutz M, Buchs N, Heller M. Cause or effect of arteriogenesis: compositional alterations of microparticles from CAD patients undergoing external counterpulsation therapy. PLoS One. 2012;7(10):e46822. doi: 10.1371/journal.pone.0046822. Epub 2012 Oct 8.

Reference Type DERIVED
PMID: 23056467 (View on PubMed)

Other Identifiers

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61/06

Identifier Type: -

Identifier Source: org_study_id