Clinical trial NCT00414297: External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Official title: External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CAD
ECP
CFI
CPI
MPR
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2006-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: Collateral flow index (CFI)
timeFrame: 21 days
measure: Coronary collateral resistance (Rcoll)
timeFrame: 21 days
Secondary outcomes:
measure: Myocardial perfusion reserve
timeFrame: 21 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital
Study officials:
affiliation: University of Bern
name: Christian Seiler, MD, Prof.
role: STUDY_CHAIR
affiliation: University of Bern
name: Steffen Gloekler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.