Remote Ischemic Preconditioning in Cardiac Surgery Trial (Remote IMPACT)

Remote Ischemic Preconditioning in Cardiac Surgery: a Pilot Randomized Controlled Trial

Main Research Questions:

1. Is a large trial of patients undergoing heart surgery comparing a simple procedure of temporarily stopping blood flow to the leg with a blood pressure cuff (called remote ischemic preconditioning) to a sham procedure possible?
2. Does the remote ischemic preconditioning procedure before heart surgery help protect the heart and kidneys?

What is Being Studied:

A simple procedure known as remote ischemic preconditioning. The procedure is performed by inflating a pressurized cuff the thigh to temporarily stop blood flow to the arm or leg. This procedure causes the body to have a stress response that, at the cellular level, may protect major organs like the heart and kidney from the damage caused to them by the much larger stress of cardiac surgery. Reducing this damage may improve patient's recovery after surgery and help them live longer.

Why is this study important?:

This research is important because up to 1 in every 20 patients that undergo heart surgery die before even leaving hospital. Preventing heart and kidney damage at the time of surgery with remote ischemic preconditioning may reduce patient deaths.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Procedure: Sham; Procedure: Remote Ischemic Preconditioning

Detailed Description

Annually, 2 million patients worldwide undergo heart surgery. Although this procedure can prolong life, 1 in 20 patients will not survive their hospital stay. Acute heart and kidney injuries are important causes of death after heart surgery. Remote ischemic preconditioning (RIPC) is a promising and simple therapy that may simultaneously reduce heart and kidney damage. RIPC involves the inflation of a tourniquet or blood pressure cuff on a limb to briefly stop blood flow to that limb. This period of no blood flow activates the body's own protective systems and releases protective chemicals into the blood that also protect the heart and kidneys. RIPC is a particularly attractive potential treatment because it may protect several organs at once, it has no known adverse effects and costs almost nothing. RIPC could therefore very easily be used globally to improve outcomes for all patients undergoing heart surgery. Although RIPC appears very promising in several small studies using different RIPC regimens there are no studies large enough to definitively evaluate whether RIPC improves patient important outcomes (e.g. survival, kidney failure, major heart attack, or stroke). Before performing a large trial to determine whether RIPC is effective, we must demonstrate that such a trial is feasible. We will determine the recruitment rate and adequacy of follow-up in an international group of centres to ensure that an adequately powered trial of RIPC compared to a sham procedure is possible. Further, we will ensure that our RIPC regimen is consistent with other trials in terms of effects on cardiac and kidney injury. This pilot trial will enroll 250 patients and randomize half to RIPC and half to a sham procedure. We call this trial the Remote IscheMia Preconditioning in cArdiaC surgery Trial (Remote IMPACT).

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Maritime Heart Centre
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster University
    • London, Ontario, Canada
      • Lawson Health Research Institute
    • Toronto, Ontario, Canada
      • Sunnybrook Hospital
• United States
  • Maine
    • Portland, Maine, United States
      • Maine Medical Centre
  • North Carolina
    • Winston-Salem, North Carolina, United States
      • Wake Forest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• undergoing cardiac surgery
• at least 18 years old
• EuroSCORE >= 6

Exclusion Criteria:

• requiring intra-aortic balloon pump support prior to surgery
• unable to provide informed consent or decline to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham RIPC; Inflation of thigh pneumatic tourniquet to <15 mmHg	Procedure: Sham; Sham procedure. A pneumatic tourniquet is placed on an upper arm and/or thigh but not inflated.
Active Comparator: Active RIPC; 300 mmHg inflation of thigh pneumatic tourniquet for three cycles of 5 minutes each with 5 minutes of no inflation between cycles.	Procedure: Remote Ischemic Preconditioning; Occlusion of leg blood flow using a pneumatic tourniquet on the thigh. Tourniquets are inflated to 300 mmHg for 5 minutes followed by deflation for 5 minutes then repeated for a total of 3 inflations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak CK-MB within 24 hours after surgery	Peak CK-MB within 24 hours after surgery	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in serum creatinine	within 4 days after surgery
All-cause mortality	6 months after surgery
Need for Dialysis	6 months after surgery
Length of hospital stay	Discharge from hospital after surgery
Length of stay in the intensive care unit	Discharge from hospital after surgery
Incidence of pneumonia	30 days after surgery
Incidence of stroke	6 months after surgery

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Michael Walsh, MD MSc, McMaster University; Principal Investigator: PJ Devereaux, MD PhD, McMaster University

Publications and helpful links

General Publications

• Walsh M, Whitlock R, Garg AX, Legare JF, Duncan AE, Zimmerman R, Miller S, Fremes S, Kieser T, Karthikeyan G, Chan M, Ho A, Nasr V, Vincent J, Ali I, Lavi R, Sessler DI, Kramer R, Gardner J, Syed S, VanHelder T, Guyatt G, Rao-Melacini P, Thabane L, Devereaux PJ; Remote IMPACT Investigators. Effects of remote ischemic preconditioning in high-risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial. CMAJ. 2016 Mar 15;188(5):329-336. doi: 10.1503/cmaj.150632. Epub 2015 Dec 14.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 18, 2010
• First Posted (Estimate): February 19, 2010

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 09-536; NIF-09223 (Other Grant/Funding Number: Hamilton Health Sciences New Investigator Fund); CANNeCTIN Funding (Other Grant/Funding Number: Canadian Network and Centre for Trials Internationally)