Resynchronization Surgery Combined Unified Efficacy (RESCUE)

Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients

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 )

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Failure
• Intervention / Treatment: Procedure: Coronary artery bypass grafting; Device: Epicardial implantation of cardiac resynchronization therapy device

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Katowice, Poland
    • Medical University of Silesia
• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • State Research Institute of Circulation Pathology
• Slovenia
  • Ljubljana, Slovenia
    • University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CABG alone; Standard coronary artery bypass grafting according guidelines	Procedure: Coronary artery bypass grafting; Standard coronary surgry according guidelines
EXPERIMENTAL: CABG+CRT; Standard coronary artery bypass grafting according guidelines with concomitant three bipolar epicardial leads implantation for cardiac resynchronization therapy	Procedure: Coronary artery bypass grafting; Standard coronary surgry according guidelines; Device: Epicardial implantation of cardiac resynchronization therapy device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long-term mortality	6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Mode of Death	6 years
Adverse cardiac events	6 years
Lead performance	6 years

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Collaborators: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Evgeny A Pokushalov, MD, PhD, Prof., State Research Institute of Circulation Pathology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: February 16, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (ESTIMATE): February 18, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Resynchronization Therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SACRT 022; RU 001