Viewing Study NCT00414297



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Study NCT ID: NCT00414297
Status: COMPLETED
Last Update Posted: 2010-10-26
First Post: 2006-12-20

Brief Title: External Counterpulsation ECP for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Sponsor: Insel Gruppe AG University Hospital Bern
Organization: Insel Gruppe AG University Hospital Bern

Study Overview

Official Title: External Counterpulsation ECP for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Status: COMPLETED
Status Verified Date: 2010-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ie Collateral Flow Index and myocardial perfusion is performed with calculation of the CPI ie Collateral Perfusion Index and MPR ie Myocardial Perfusion Reserve

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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None