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

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00414297

Purpose

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.

Condition	Intervention
Coronary Artery Disease	Device: ECP Therapy

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

Collateral flow index (CFI) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Coronary collateral resistance (Rcoll) [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Myocardial perfusion reserve [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 ECP: Active Comparator active ECP Therapy	Device: ECP Therapy application of ECP Therapy to CAD Patients
2: Placebo Comparator Sham ECP Treatment	Device: ECP Therapy application of ECP Therapy to CAD Patients

Detailed Description:

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 .

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414297

Contacts

Contact: Steffen Gloekler, MD

+41 31 632 1276

steffen.gloekler@insel.ch

Locations

Switzerland
Bern University Hospital	Recruiting
Bern, Switzerland, 3010
Sub-Investigator: Pascal Meier, MD
Sub-Investigator: Tobias Rutz, MD
Sub-Investigator: Stefano de Marchi, MD

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Study Chair:	Christian Seiler, MD, Prof.	University of Bern
Principal Investigator:	Steffen Gloekler, MD	University of Bern

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Cardiology ( BernUniversity Hospital )
Study ID Numbers:	KEK61_06
Study First Received:	December 20, 2006
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00414297
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

CAD
ECP
CFI
CPI
MPR

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009