Resynchronization Surgery Combined Unified Efficacy (RESCUE)
Tracking Information
Start Date ICMJE | September 2007 |
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Estimated Primary Completion Date | September 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 ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00846001 on ClinicalTrials.gov Archive Site |
Descriptive Information
Brief Title ICMJE | Resynchronization Surgery Combined Unified Efficacy |
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Official Title ICMJE | Study 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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Condition ICMJE | Ischemic Heart Failure |
Intervention ICMJE | 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. |
Recruitment Information
Estimated Enrollment ICMJE | 250 | ||||||||
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Estimated Completion Date | December 2011 | ||||||||
Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 80 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Administrative Information
NCT ID ICMJE | NCT00846001 | ||||
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Responsible Party | Evgeny Pokushalov, State Research Institute of Circulation Pathology | ||||
Study ID Numbers ICMJE | SACRT 022, RU 001 | ||||
Study Sponsor ICMJE | Meshalkin Research Institute of Pathology of Circulation | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Meshalkin Research Institute of Pathology of Circulation |
Source: http://clinicaltrials.gov/