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Revascularization in Heart Failure Trial – REHEAT 2

This study is not yet open for participant recruitment.
Verified by Ministry of Science and Higher Education, Poland, October 2006

Sponsored by: Ministry of Science and Higher Education, Poland
Information provided by: Ministry of Science and Higher Education, Poland
ClinicalTrials.gov Identifier: NCT00388245
  Purpose

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.


Condition Intervention Phase
Left Ventricular Ejection Fraction
Myocardial Revascularization
Ischemic Heart Disease
Procedure: Percutaneous Coronary Intervention
Procedure: Coronary Artery Bypass Grafting
Phase IV

MedlinePlus related topics:   Cardiomyopathy    Coronary Artery Bypass Surgery    Heart Diseases    Heart Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Myocardial Revascularization in Patients With Ischemic Cardiomyopathy: a Comparison Between Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery

Further study details as provided by Ministry of Science and Higher Education, Poland:

Primary Outcome Measures:
  • LV ejection fraction after 1 year since the index procedure

Secondary Outcome Measures:
  • 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.

Estimated Enrollment:   150
Study Start Date:   January 2007
Estimated Study Completion Date:   December 2008

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.

  Eligibility
Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388245

Contacts
Contact: Pawel E Buszman, Prof     +48 32 252 72 12     pbuszman@ka.onet.pl    
Contact: Iwona Szkrobka, MD     +48 602 457 602     wilenka@wp.pl    

Locations
Poland
Military Clinic Hospital     Not yet recruiting
      Wroclaw, Poland, 50-981
      Principal Investigator: Piotr Ponikowski, Prof            
Central Clinic Hospital     Not yet recruiting
      Warsaw, Poland, 02-507
      Principal Investigator: Robert J Gil, Prof            
Poland, Silesia
University School of Silesia, 1-st Department of Cardiosurgery     Not yet recruiting
      Katowice, Silesia, Poland, 40-635
      Principal Investigator: Andrzej Bochenek, Prof            
University School of Silesia, 3-rd Department of Cardiology, Coronary Care Unit     Not yet recruiting
      Katowice, Silesia, Poland, 40-635
      Principal Investigator: Pawel E Buszman, Prof            
      Sub-Investigator: Iwona Szkrobka, MD            
      Principal Investigator: Michal Tendera, Prof            
      Sub-Investigator: Aleksander Zurakowski, PhD            

Sponsors and Collaborators
Ministry of Science and Higher Education, Poland

Investigators
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    
  More Information


Publications of Results:
Serruys PW, Ong AT, van Herwerden LA, Sousa JE, Jatene A, Bonnier JJ, Schonberger 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.
 

Study ID Numbers:   0213/P01/2006/31
First Received:   October 13, 2006
Last Updated:   October 13, 2006
ClinicalTrials.gov Identifier:   NCT00388245
Health Authority:   Poland: Ministry of Scientific Research and Information Technology

Keywords provided by Ministry of Science and Higher Education, Poland:
PCI  
CABG  
Ejection Fraction  
Myocardial Revascularization  

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Cardiomyopathies

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2008




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