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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

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Detailed Description:

Purpose:

  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
  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

Hypothesis:

We hypothesize that rIP provides myocardial protection in patients presenting for heart surgery and that this protection is defined by a distinct gene expression profile with regards to genes involved in rIP and myocardial metabolism.

Study Design:

This proposal is for a randomized blinded pilot study on the use of rIP in patients requiring heart surgery.

Study Population:

The study will include 100 male and female patients undergoing elective heart surgery with cardiopulmonary bypass (CPB).

Randomization:

Patients will be randomized 1:1 to receive either rIP or no treatment.

Blinding Procedures:

The patient will be blinded as well as those performing the experimental analysis.

Interventions:

Remote Ischemic Preconditioning

rIP will be induced immediately following induction of anesthesia. Four 5 minute cycles of lower unilateral limb ischemia and reperfusion induced tourniquet inflation to 300 mmHg will constitute the preconditioning stimulus.

Blood sample collection/analysis

  1. Two cardiac biopsies (50 - 200 mg) will be collected pre-bypass and post- bypass and will be analyzed for gene and protein expression.
  2. Blood samples (4 mL) will be drawn immediately before induction of anesthesia, and at the same times as cardiac tissue samples are harvested and analyzed for gene/protein expression as well as at 1, 24, 48 and 72 hours post surgery. Troponin I and NT-ProBNP will be measured at baseline, 1, 24, 48 and 72 hours after surgery and 3 mL of blood will be collected for these tests. A total of 43 mL of blood will be collected per patient.
  3. rIP induced changes in leukocyte gene expression will be measured at the aforementioned time points.

Other

ECG assessment on post-operative day 1, 2, and 3.

National Institute of Health stroke scale assessment will be conducted at screening and post operatively prior to hospital discharge.

Each patient will receive a telephone follow-up call at 30 days post operatively to collect adverse events and mortality data.

Experimental Methods:

  1. qRT-PCR will be used to measure gene expression.
  2. Immunoblotting will be used to measure protein expression

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
U.S. FDA Resources

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, Senior)
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