Status:
UNKNOWN
Revascularization in Heart Failure Trial - REHEAT 2
Lead Sponsor:
Ministry of Science and Higher Education, Poland
Conditions:
Left Ventricular Ejection Fraction
Myocardial Revascularization
Eligibility:
All Genders
19-90 years
Phase:
PHASE4
Brief Summary
REHEAT 2 study is designed as a prospective, randomised trial comparing two strategies of myocardial revascularisation (PCI vs CABG) in patients with ischemic cardiomyopathy and low left ventricular e...
Detailed Description
Heart failure constitutes one of basic problems of contemporary cardiology. It is most commonly caused by ischaemic heart disease, which as an etiologic factor, has a negative impact on prognosis. On ...
Eligibility Criteria
Inclusion
- symptomatic coronary artery disease (angina CCS class 1)
- left ventricle ejection fraction \<40%
- coronary artery lesions suitable for percutaneous or surgical myocardial revascularisation
- evidence for viability of the myocardium
- written inform consent for the study
Exclusion
- age \<18 years
- acute myocardial infarct with ST elevation within 30 days
- concomitant congenital heart disease
- mitral regurgitation required surgical intervention
- history of bleeding diathesis, coagulopathy or abnormal bleeding within the previous 30 days.
- major surgery within the previous 6 weeks
- stroke or transient ischemic attack (TIA) within the previous 6 weeks
- history of hemorrhagic stroke
- uncontrolled hypertension
- chronic renal insufficiency with creatinine \>2.0 mg/dl
- platelet count \<100.000/mm3
- hematocrit \<30%
- PT \>1,2 times control
- positive pregnancy test
- any disease that may shorten the life expectancy of the patient
- the patient is currently participating in another research study
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00388245
Start Date
January 1 2007
End Date
December 1 2008
Last Update
October 16 2006
Active Locations (4)
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1
University School of Silesia, 1-st Department of Cardiosurgery
Katowice, Silesian Voivodeship, Poland, 40-635
2
University School of Silesia, 3-rd Department of Cardiology, Coronary Care Unit
Katowice, Silesian Voivodeship, Poland, 40-635
3
Central Clinic Hospital
Warsaw, Poland, 02-507
4
Military Clinic Hospital
Wroclaw, Poland, 50-981