Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study - Full Text View

Sponsor:	University of Alberta
Information provided by (Responsible Party):	Barry Finegan, University of Alberta
ClinicalTrials.gov Identifier:	NCT00546390

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:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

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

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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

No publications provided

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:	September 22, 2011
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012