Revascularization in Heart Failure Trial – REHEAT 2

Tracking Information
First Submitted Date ICMJE	October 13, 2006
First Posted Date ICMJE	October 16, 2006
Last Update Posted Date	October 16, 2006
Study Start Date ICMJE	January 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: October 13, 2006)	LV ejection fraction after 1 year since the index procedure
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: October 13, 2006)	in-hospital and 30 day major adverse events (MAE) and major adverse cardiovascular events (MACE) defined as: death, AMI, stroke, acute heart failure, re-CABG, re-PTCA;; major adverse coronary and cerebrovascular events during 1 year follow-up (MACCE): death, repeat revascularisation, AMI, unstable angina, heart transplantation, heart failure stroke;; long term survival;; severity of angina, exercise and functional capacity along with assessment of quality of life in one year observation.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Revascularization in Heart Failure Trial – REHEAT 2
Official Title ICMJE	Myocardial Revascularization in Patients With Ischemic Cardiomyopathy: a Comparison Between Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery
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 ejection fraction.Patients will undergo in random way PCI or CABG procedure. The aim the study is to assess the improvement of left ventricle systolic function and comparing recent (30 days) and late (12 months) results of surgical (CABG) and percutaneous (PCI) revascularization.
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 the other hand, decreased left ventricular ejection fraction is the most important prognostic factor in patients with ischaemic heart disease. Annual mortality among patients with ejection fraction below 35% accounts for 17%, and in a group with ejection fraction below 25% reaches 24%. Most of multicenter studies (e.g. ARTS, BARI, ERACI) comparing results of percutaneous and surgical revascularisation in ischemic heart disease pertain to patients with normal or minimally decreased left ventricular ejection fraction, excluding patients with left ventricular ejection fraction lower than 35%. Current medical standards indicate the surgical way as a method of choice in treatment of patients with ischemic cardiomyopathy. In early nineties the procedures of percutaneous angioplasty in patients with depressed left ventricular function were connected with comparable to CABG risk of death (5-10%). The intensive progress of percutaneous procedures contributed PCI is competitive method of revasularization to CABG. Our knowledge about the efficacy of above mentioned methods in patients with ischemic heart failure is scarce until now. It was proved, that patients with viable myocardium assessed in dobutamine stress echocardiography or MRI benefit mostly from myocardial revascularization. Repeat revascularization during follow up occurred more frequently in patients after PCI, so that introduction of coronary stents, especially drug eluting stents (DES) could significantly improve the clinical outcome after PCI procedures. The administration of antiplatelet drugs (IIb/IIIa platelet receptor inhibitors) have considerably improved the short and long-term results of PCI so that it is interesting if they could have beneficial effect on clinical outcome of patients with ischemic heart failure. In the field of cardiac surgery the method of left ventricle reconstruction in patients with ischemic cardiomyopathy (STICH Trial) seems to be promising. Therefore, the comparison of innovative methods of percutaneous and surgical revascularization may influence current medical standards concerning patients with ischemic heart disease.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Left Ventricular Ejection Fraction; Myocardial Revascularization; Ischemic Heart Disease
Intervention ICMJE	Procedure: Percutaneous Coronary Intervention; Procedure: Coronary Artery Bypass Grafting
Study Arms	Not Provided
Publications *	Serruys PW, Ong AT, van Herwerden LA, Sousa JE, Jatene A, Bonnier JJ, Schönberger JP, Buller N, Bonser R, Disco C, Backx B, Hugenholtz PG, Firth BG, Unger F. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J Am Coll Cardiol. 2005 Aug 16;46(4):575-81.; Scholz KH, Dubois-Rande JL, Urban P, Morice MC, Loisance D, Smalling RW, Figulla HR. Clinical experience with the percutaneous hemopump during high-risk coronary angioplasty. Am J Cardiol. 1998 Nov 1;82(9):1107-10, A6.; Shawl FA, Quyyumi AA, Bajaj S, Hoff SB, Dougherty KG. Percutaneous cardiopulmonary bypass-supported coronary angioplasty in patients with unstable angina pectoris or myocardial infarction and a left ventricular ejection fraction < or = 25%. Am J Cardiol. 1996 Jan 1;77(1):14-9.; Van Belle E, Blouard P, McFadden EP, Lablanche JM, Bauters C, Bertrand ME. Effects of stenting of recent or chronic coronary occlusions on late vessel patency and left ventricular function. Am J Cardiol. 1997 Nov 1;80(9):1150-4.; Bax JJ, Poldermans D, Elhendy A, Cornel JH, Boersma E, Rambaldi R, Roelandt JR, Fioretti PM. Improvement of left ventricular ejection fraction, heart failure symptoms and prognosis after revascularization in patients with chronic coronary artery disease and viable myocardium detected by dobutamine stress echocardiography. J Am Coll Cardiol. 1999 Jul;34(1):163-9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Enrollment ICMJE; (submitted: October 13, 2006)	150
Original Enrollment ICMJE	Same as current
Study Completion Date	December 2008
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Criteria: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	19 Years to 90 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Poland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00388245
Other Study ID Numbers ICMJE	0213/P01/2006/31
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Ministry of Science and Higher Education, Poland
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Pawel E Buszman, Prof 3-rd Division of Cardiology, University School of Silesia, Poland Study Chair: Michal Tendera, Prof 3-rd Division of Cardiology, University School of Silesia, Poland Principal Investigator: Andrzej Bochenek, Prof 1-st Division of Cardiosurgery, University School of Silesia, Poland Principal Investigator: Robert J Gil, Prof Invasive Cardiology Department, Central Clinic Hospital, Warsaw, Poland Principal Investigator: Piotr Ponikowski, Prof Heart Disease Department, Military Clinic Hospital, Wroclaw, Poland
PRS Account	Ministry of Science and Higher Education, Poland
Verification Date	October 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP