Revascularization in Heart Failure Trial – REHEAT 2

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Ministry of Science and Higher Education, Poland.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ministry of Science and Higher Education, Poland
ClinicalTrials.gov Identifier:
NCT00388245
First received: October 13, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Myocardial Revascularization in Patients With Ischemic Cardiomyopathy: a Comparison Between Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery

Resource links provided by NLM:


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
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         
Central Clinic Hospital Not yet recruiting
Warsaw, Poland, 02-507
Principal Investigator: Robert J Gil, Prof         
Military Clinic Hospital Not yet recruiting
Wroclaw, Poland, 50-981
Principal Investigator: Piotr Ponikowski, Prof         
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:
ClinicalTrials.gov Identifier: NCT00388245     History of Changes
Other Study ID Numbers: 0213/P01/2006/31
Study First Received: October 13, 2006
Last Updated: October 13, 2006
Health Authority: Poland: Ministry of Science and Higher Education

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014