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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 16, 2009

Last Updated Date

August 10, 2011

Start Date ^ICMJE

September 2007

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Resynchronization Surgery Combined Unified Efficacy

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

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.

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

250

Completion Date

September 2010

Primary Completion Date

September 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland, Russian Federation, Slovenia

Administrative Information

NCT Number ^ICMJE

NCT00846001

Other Study ID Numbers ^ICMJE

SACRT 022, RU 001

Has Data Monitoring Committee

Yes

Responsible Party

Evgeny Pokushalov, State Research Institute of Circulation Pathology

Study Sponsor ^ICMJE

Meshalkin Research Institute of Pathology of Circulation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Evgeny A Pokushalov, MD, Prof.

State Research Institute of Circulation Pathology

Information Provided By

Meshalkin Research Institute of Pathology of Circulation

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top