Remote Ischemic Preconditioning in Cardiac Surgery Trial (Remote IMPACT)

This study has been completed.
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01071265
First received: February 18, 2010
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cardiac Surgery
Procedure: Remote Ischemic Preconditioning
Procedure: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning in Cardiac Surgery: a Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Myocardial Injury [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum creatinine [ Time Frame: within 4 days after surgery ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 6 months after surgery ] [ Designated as safety issue: Yes ]
  • Need for Dialysis [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Discharge from hospital after surgery ] [ Designated as safety issue: No ]
  • Length of stay in the intensive care unit [ Time Frame: Discharge from hospital after surgery ] [ Designated as safety issue: No ]
  • Incidence of pneumonia [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
  • Incidence of stroke [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • Peak CK-MB [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Peak CK-MB within 24 hours after surgery


Enrollment: 250
Study Start Date: March 2011
Study Completion Date: January 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071265

Locations
United States, Maine
Maine Medical Centre
Portland, Maine, United States
United States, North Carolina
Wake Forest
Winston-Salem, North Carolina, United States
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
Canada, Nova Scotia
Maritime Heart Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Lawson Health Research Institute
London, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Michael Walsh, MD MSc McMaster University
Principal Investigator: PJ Devereaux, MD PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01071265     History of Changes
Other Study ID Numbers: 09-536, NIF-09223, CANNeCTIN Funding
Study First Received: February 18, 2010
Last Updated: May 15, 2013
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on July 26, 2014