Revascularization in Heart Failure Trial - REHEAT 2

Myocardial Revascularization in Patients With Ischemic Cardiomyopathy: a Comparison Between Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery

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.

Study Overview

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

Interventional

Enrollment

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Iwona Szkrobka, MD
  • Phone Number: +48 602 457 602
  • Email: wilenka@wp.pl

Study Locations

      • Warsaw, Poland, 02-507
        • Central Clinic Hospital
        • Principal Investigator:
          • Robert J Gil, Prof
      • Wroclaw, Poland, 50-981
        • Military Clinic Hospital
        • Principal Investigator:
          • Piotr Ponikowski, Prof
    • Silesia
      • Katowice, Silesia, Poland, 40-635
        • University School of Silesia, 1-st Department of Cardiosurgery
        • Principal Investigator:
          • Andrzej Bochenek, Prof
      • Katowice, Silesia, Poland, 40-635
        • University School of Silesia, 3-rd Department of Cardiology, Coronary Care Unit
        • Principal Investigator:
          • Pawel E Buszman, Prof
        • Sub-Investigator:
          • Iwona Szkrobka, MD
        • Principal Investigator:
          • Michal Tendera, Prof
        • Sub-Investigator:
          • Aleksander Zurakowski, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
LV ejection fraction after 1 year since the index procedure

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

October 13, 2006

First Submitted That Met QC Criteria

October 13, 2006

First Posted (Estimate)

October 16, 2006

Study Record Updates

Last Update Posted (Estimate)

October 16, 2006

Last Update Submitted That Met QC Criteria

October 13, 2006

Last Verified

October 1, 2006

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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