Resynchronization Surgery Combined Unified Efficacy (RESCUE)


Tracking Information

Start Date  ICMJESeptember 2007
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 17, 2009)		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 ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00846001 on ClinicalTrials.gov Archive Site

Descriptive Information

Brief Title  ICMJEResynchronization Surgery Combined Unified Efficacy
Official Title  ICMJEStudy of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients
Brief Summary

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)

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Condition  ICMJEIschemic Heart Failure
Intervention  ICMJEProcedure: 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.

Recruitment Information

Estimated Enrollment  ICMJE250
Estimated Completion DateDecember 2011
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Evgeny A Pokushalov, MD, Prof.+7 383 332 76 55E.Pokushalov@gmail.com
Contact: Alexander B Romanov, MD+7 383 332 76 55abromanov@mail.ru

Administrative Information

NCT ID  ICMJENCT00846001
Responsible PartyEvgeny Pokushalov, State Research Institute of Circulation Pathology
Study ID Numbers  ICMJESACRT 022, RU 001
Study Sponsor  ICMJEMeshalkin Research Institute of Pathology of Circulation
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Evgeny A Pokushalov, MD, Prof.State Research Institute of Circulation Pathology
Information Provided ByMeshalkin Research Institute of Pathology of Circulation