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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

October 16, 2007
February 14, 2012
November 2007
April 2010   (final data collection date for primary outcome measure)
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 ]
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-, p38 MAPK, PI3K, and sarcolemmal KATP
Complete list of historical versions of study NCT00546390 on ClinicalTrials.gov Archive Site
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 ]
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-1, PPAR- and AMPK
Not Provided
Not Provided
 
Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Remote Ischemic Preconditioning
  • Myocardial Protection
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.
  • Experimental: 1
    Will receive rIP
    Intervention: Device: Blood Pressure Cuff
  • No Intervention: 2
Lucchinetti E, Bestmann L, Feng J, Freidank H, Clanachan AS, Finegan BA, Zaugg M. Remote ischemic preconditioning applied during isoflurane inhalation provides no benefit to the myocardium of patients undergoing on-pump coronary artery bypass graft surgery: lack of synergy or evidence of antagonism in cardioprotection? Anesthesiology. 2012 Feb;116(2):296-310.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00546390
Protect
No
Barry Finegan, University of Alberta
University of Alberta
Not Provided
Principal Investigator: Barry A Finegan, MB University of Alberta
University of Alberta
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP