Enhanced External Counterpulsation

This study has been completed.
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01355315
First received: June 18, 2008
Last updated: May 17, 2011
Last verified: June 2008

June 18, 2008
May 17, 2011
April 2006
December 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01355315 on ClinicalTrials.gov Archive Site
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Enhanced External Counterpulsation
Enhanced External Counterpulsation for Ischemic Cardiomyopathy

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

serum and plasma

Probability Sample

Patients with ischemia coronary artery diseases and congestive heart failure not amenable to standard procedures

  • Coronary Artery Disease
  • Congestive Heart Failure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
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December 2007   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01355315
95005, FEMH-95-C-039
Yes
Shih-Hong Huang, Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
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Far Eastern Memorial Hospital
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP