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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barry Finegan, University of Alberta
ClinicalTrials.gov Identifier:
NCT00546390
First received: October 16, 2007
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Barry Finegan, MB, FFARC, FRCPC, University of Alberta
ClinicalTrials.gov Identifier: NCT00546390     History of Changes
Other Study ID Numbers: Protect
Study First Received: October 16, 2007
Last Updated: February 14, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014