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Resynchronization Surgery Combined Unified Efficacy (RESCUE)

Primary Purpose

Ischemic Heart Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Coronary artery bypass grafting
Epicardial implantation of cardiac resynchronization therapy device
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Failure focused on measuring Resynchronization Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women
  • Age 18-80
  • History of ischemic heart failure and indications for CABG
  • 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 cardiac surgery
  • 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

Sites / Locations

  • Medical University of Silesia
  • State Research Institute of Circulation Pathology
  • University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CABG alone

CABG+CRT

Arm Description

Standard coronary artery bypass grafting according guidelines

Standard coronary artery bypass grafting according guidelines with concomitant three bipolar epicardial leads implantation for cardiac resynchronization therapy

Outcomes

Primary Outcome Measures

Long-term mortality

Secondary Outcome Measures

Mode of Death
Adverse cardiac events
Lead performance

Full Information

First Posted
February 16, 2009
Last Updated
July 14, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00846001
Brief Title
Resynchronization Surgery Combined Unified Efficacy
Acronym
RESCUE
Official Title
Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to compare survivability and efficacy of the patients with severe ischemic heart failure after coronary artery bypass grafting alone and coronary artery bypass grafting with single-step implantation of CRT system (CABG alone vs CABG + CRT )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Failure
Keywords
Resynchronization Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CABG alone
Arm Type
Active Comparator
Arm Description
Standard coronary artery bypass grafting according guidelines
Arm Title
CABG+CRT
Arm Type
Experimental
Arm Description
Standard coronary artery bypass grafting according guidelines with concomitant three bipolar epicardial leads implantation for cardiac resynchronization therapy
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass grafting
Intervention Description
Standard coronary surgry according guidelines
Intervention Type
Device
Intervention Name(s)
Epicardial implantation of cardiac resynchronization therapy device
Intervention Description
During the cardiac surgery, the CABG+CRT arm patients 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.
Primary Outcome Measure Information:
Title
Long-term mortality
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Mode of Death
Time Frame
6 years
Title
Adverse cardiac events
Time Frame
6 years
Title
Lead performance
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women Age 18-80 History of ischemic heart failure and indications for CABG 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 cardiac surgery 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny A Pokushalov, MD, PhD, Prof.
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Silesia
City
Katowice
Country
Poland
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
University Medical Center
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20447832
Citation
Pokushalov E, Romanov A, Prohorova D, Cherniavsky A, Goscinska-Bis K, Bis J, Bochenek A, Karaskov A. Coronary artery bypass grafting with concomitant cardiac resynchronisation therapy in patients with ischaemic heart failure and left ventricular dyssynchrony. Eur J Cardiothorac Surg. 2010 Dec;38(6):773-80. doi: 10.1016/j.ejcts.2010.03.036. Epub 2010 May 6.
Results Reference
result
PubMed Identifier
20534420
Citation
Pokushalov E, Romanov A, Prohorova D, Cherniavsky A, Karaskov A, Gersak B. Coronary artery bypass grafting with and without concomitant epicardial cardiac resynchronization therapy in patients with ischemic cardiomyopathy: a randomized study. Heart Surg Forum. 2010 Jun;13(3):E177-84. doi: 10.1532/HSF98.20091149.
Results Reference
result
PubMed Identifier
26719401
Citation
Romanov A, Goscinska-Bis K, Bis J, Chernyavskiy A, Prokhorova D, Syrtseva Y, Shabanov V, Alsov S, Karaskov A, Deja M, Krejca M, Pokushalov E. Cardiac resynchronization therapy combined with coronary artery bypass grafting in ischaemic heart failure patients: long-term results of the RESCUE study. Eur J Cardiothorac Surg. 2016 Jul;50(1):36-41. doi: 10.1093/ejcts/ezv448. Epub 2015 Dec 30.
Results Reference
derived

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Resynchronization Surgery Combined Unified Efficacy

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