Enhanced External Counterpulsation

Completed

• Conditions: Coronary Artery Disease; Congestive Heart Failure

• Registration Number: NCT01355315
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

Enhanced external counterpulsation (EECP) is a noninvasive circulatory assist device that has been as a treatment option for refractory angina in left ventricular (LV) dysfunction. Recently, its potential role in heart failure management has been shown. However, although the concept of EECP was introduced almost four decades ago, and despite growing evidence supporting the clinical benefit and safety of this therapeutic modality, little is firmly established regarding the mechanisms responsible for the benefit of EECP include improvement in endothelial function, promotion of coronary collateralization, enhancement of ventricular function, and peripheral effects. Therefore, the major aim of this study is to provide an alternative treatment, EECP, for those unsuitable for standard procedures, especially for patients whose heart failure was caused by repeated myocardial infarction, called ischemic cardiomyopathy (ICMP), and to evaluate the clinical outcome and the endothelial function before and after 35 hours of EECP treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-12
• Status Verified: 2008-06
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2011-05-17
• Last Update Submitted: 2011-05-17
• Study First Posted: 2011-05-18
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• The inclusion criteria is left ventricular ejection fraction (LVEF) less than 40% by means of left ventricular angiography and symptomatic mild-to-moderate heart failure (New York Heart Association [NYHA] functional class II-III). The patient was included if there is no suitable target for either percutaneous coronary intervention or surgical bypass grafting.

Exclusion Criteria

• IF he/she has moderate or severe aortic regurgitation (AR), history of deep vein thrombosis, or significant arrhythmia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified