Resynchronization Surgery Combined Unified Efficacy (RESCUE)

This study has been completed.
Sponsor:
Information provided by:
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT00846001
First received: February 16, 2009
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

The purpose of the study is to compare survivability of the patients with ischemic heart failure LVEF ≤ 35% after coronary artery bypass grafting or coronary artery bypass grafting combined with surgical ventricular restoration and single-step implantation of CRT system and isolated coronary artery bypass grafting or coronary artery bypass grafting with surgical ventricular restoration. (CABG + CRT or CABG + SVR + CRT vs CABG or CABG + SVR)


Condition Intervention Phase
Ischemic Heart Failure
Procedure: Coronary artery bypass grafting or coronary artery bypass grafting combined with surgical ventricular restoration and single-step epicardial implantation of CRT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Null Hypothesis (Ho): There is no survival benefit in the CRT group (CABG-with or without SVR-+ CRT) compared to the control group. H0: Ө ≤ 1. Alternative Hypothesis (Ha): There is a survival benefit in the CRT group. HA: Ө > 1 [ Time Frame: 2007-2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: September 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Coronary artery bypass grafting or coronary artery bypass grafting combined with surgical ventricular restoration and single-step epicardial implantation of CRT
    During the cardiac surgery, the CRT arm will be implanted with epicardial leads to the right atrium, right and left ventricles. Left ventricle leads will be fixed to the posterolateral wall provided that there is no scar or fat tissue (behind and 2-3 cm apical than obtuse marginal artery). Right atrial and right ventricular leads will be fixed in a traditional way. Then the leads will be guided into a preformed pocket (left subclavian region) and connected with the CRT device. The second patient group will get only a CABG or CABG+SVR procedure without CRT device implantation.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women
  • Age 18-80
  • History of ischemic heart failure and indications for CABG or CABG and SVR
  • LVEF less than 35% estimated by echocardiography measured within 3 months of study entry
  • NYHA and CCS (angina) II-IV functional class
  • Signs of dyssynchrony (at least one of the following three): QRS > 120 ms or dyssynchrony based on Doppler-methods (Tissue Tracking and TSI methods) or CARE HF criteria: Aortic pre-ejection delay >140ms, Interventricular mechanical delay >40 ms, Delayed activation of postero-lateral LV wall

Exclusion Criteria:

  • Failure to provide informed consent.
  • Previous heart surgery (CABG or CABG+SVR)
  • Non-cardiac illness with a life expectancy of less than 3 year
  • Non-cardiac illness imposing substantial operative mortality
  • Previous heart, kidney, liver, or lung transplantation
  • Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device
  • Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
  • Chronic atrial fibrillation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846001

Locations
Poland
Medical University of Silesia
Katowice, Poland
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Slovenia
University Medical Center
Ljubljana, Slovenia
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, Prof. State Research Institute of Circulation Pathology
  More Information

Publications:
Responsible Party: Evgeny Pokushalov, State Research Institute of Circulation Pathology
ClinicalTrials.gov Identifier: NCT00846001     History of Changes
Other Study ID Numbers: SACRT 022, RU 001
Study First Received: February 16, 2009
Last Updated: August 10, 2011
Health Authority: Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014