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

This study has been completed.
Information provided by (Responsible Party):
Barry Finegan, University of Alberta Identifier:
First received: October 16, 2007
Last updated: February 14, 2012
Last verified: February 2012
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 Intervention
Remote Ischemic Preconditioning
Myocardial Protection
Device: Blood Pressure Cuff

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: November 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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

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
  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 identifier: NCT00546390

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

Responsible Party: Barry Finegan, MB, FFARC, FRCPC, University of Alberta Identifier: NCT00546390     History of Changes
Other Study ID Numbers: Protect
Study First Received: October 16, 2007
Last Updated: February 14, 2012

Additional relevant MeSH terms:
Pathologic Processes processed this record on May 24, 2017