Coronary Artery DiseaseNCT01355315
Enhanced External Counterpulsation
An observational study of Coronary Artery Disease and Congestive Heart Failure, run by Far Eastern Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Congestive Heart Failure
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ischemia coronary artery diseases and congestive heart failure not amenable to standard procedures
Who may be able to join
- 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.
Who cannot join
- IF he/she has moderate or severe aortic regurgitation (AR), history of deep vein thrombosis, or significant arrhythmia.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease, Congestive Heart Failure
- Keywords
- EECP, ischemic cardiomyopathy, endothelin-1, ischemia coronary artery diseases, congestive heart failure not amenable to standard procedures
- Medical subject headings
- Coronary Artery Disease, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startApr 2006
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355315
- Sponsor's protocol ID
- 95005
- Other IDs
- FEMH-95-C-039
- Status last verified
- Jun 2008
- First submitted
- 18 Jun 2008
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced External Counterpulsation for Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01355315
- Acronym / sponsor ID
- 95005
- Conditions
- Coronary Artery Disease, Congestive Heart Failure
- Keywords
- EECP, ischemic cardiomyopathy, endothelin-1, ischemia coronary artery diseases, congestive heart failure not amenable to standard procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2007 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ischemia coronary artery diseases and congestive heart failure not amenable to standard procedures
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- IF he/she has moderate or severe aortic regurgitation (AR), history of deep vein thrombosis, or significant arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Congestive Heart Failure, run by Far Eastern Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.