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Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00546390
Recruitment Status : Completed
First Posted : October 18, 2007
Last Update Posted : February 16, 2012
Sponsor:
Information provided by (Responsible Party):
Barry Finegan, University of Alberta

Brief Summary:
The purpose of this study is to compare a treatment called remote ischemic preconditioning (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover better after heart surgery. This treatment involves applying a large blood pressure cuff to one leg. The blood pressure cuffs will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.

Condition or disease Intervention/treatment Phase
Remote Ischemic Preconditioning Myocardial Protection Device: Blood Pressure Cuff Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
Study Start Date : November 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: 1
Will receive rIP
Device: Blood Pressure Cuff
The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.

No Intervention: 2



Primary Outcome Measures :
  1. 1) Determine, in a pilot study, if surrogate markers of rIP can be detected in patients presenting for cardiac surgery. Specifically measure the effect of rIP on the expression profile of HSP-70, iNOS, PKC-E, p38 MAPK, PI3K, and sarcolemmal KATP [ Time Frame: 72 hours post operatively ]

Secondary Outcome Measures :
  1. 2) Determine if rIP influences the expression of genes known to influence substrate preference and thereby myocardial metabolism in patients undergoing heart surgery. Specifically the expression of HIF-1a, PPAR-a and AMPK [ Time Frame: 72 hours postoperatively ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Age 18 through 80 years, inclusive
  • Scheduled for heart surgery with CPB

Exclusion Criteria:

  • Females of childbearing potential
  • Emergency surgery
  • Previous sternotomy
  • Myocardial infarction within 48 hours prior to surgery
  • Diabetes and/or BMI >35
  • Need for Alpha2-agonists perioperatively
  • Peripheral Vascular Disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546390


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Barry A Finegan, MB University of Alberta