ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhanced External Counterpulsation

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.
ClinicalTrials.gov Identifier: NCT01355315
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
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.

Condition or disease
Coronary Artery Disease Congestive Heart Failure

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enhanced External Counterpulsation for Ischemic Cardiomyopathy
Study Start Date : April 2006
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources




Biospecimen Retention:   Samples Without DNA
serum and plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

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 Posted: May 18, 2011    Key Record Dates
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