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Enhanced External Counterpulsation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355315
First Posted: May 18, 2011
Last Update Posted: May 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Far Eastern Memorial Hospital
  Purpose
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.

Condition
Coronary Artery Disease Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enhanced External Counterpulsation for Ischemic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Biospecimen Retention:   Samples Without DNA
serum and plasma

Enrollment: 19
Study Start Date: April 2006
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with ischemia coronary artery diseases and congestive heart failure not amenable to standard procedures
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Shih-Hong Huang, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01355315     History of Changes
Other Study ID Numbers: 95005
FEMH-95-C-039
First Submitted: June 18, 2008
First Posted: May 18, 2011
Last Update Posted: May 18, 2011
Last Verified: June 2008

Keywords provided by Far Eastern Memorial Hospital:
EECP
ischemic cardiomyopathy
endothelin-1
ischemia coronary artery diseases
congestive heart failure not amenable to standard procedures

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases