NCT01071265

Brief Summary

Main Research Questions:

  1. 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. 2.Does the remote ischemic preconditioning procedure before heart surgery help protect the heart and kidneys?

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

February 18, 2010

Last Update Submit

September 24, 2015

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Peak CK-MB within 24 hours after surgery

    Peak CK-MB within 24 hours after surgery

    24 hours

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Sham RIPC

PLACEBO COMPARATOR

Inflation of thigh pneumatic tourniquet to \<15 mmHg

Procedure: Sham

Active RIPC

ACTIVE COMPARATOR

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

Interventions

Remote Ischemic PreconditioningPROCEDURE

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.

Active RIPC
ShamPROCEDURE

Sham procedure. A pneumatic tourniquet is placed on an upper arm and/or thigh but not inflated.

Sham RIPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Maine Medical Centre

Portland, Maine, United States

Location

Wake Forest

Winston-Salem, North Carolina, United States

Location

University of Calgary

Calgary, Alberta, Canada

Location

Maritime Heart Centre

Halifax, Nova Scotia, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

Lawson Health Research Institute

London, Ontario, Canada

Location

Sunnybrook Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26668200DERIVED

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

  • Michael Walsh, MD MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

  • PJ Devereaux, MD PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

March 1, 2011

Primary Completion

May 1, 2012

Study Completion

January 1, 2013

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

CA(5)US(2)