Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
|ClinicalTrials.gov Identifier: NCT00546390|
Recruitment Status : Completed
First Posted : October 18, 2007
Last Update Posted : February 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Remote Ischemic Preconditioning Myocardial Protection||Device: Blood Pressure Cuff||Not Applicable|
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- 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
- 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
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.
This proposal is for a randomized blinded pilot study on the use of rIP in patients requiring heart surgery.
The study will include 100 male and female patients undergoing elective heart surgery with cardiopulmonary bypass (CPB).
Patients will be randomized 1:1 to receive either rIP or no treatment.
The patient will be blinded as well as those performing the experimental analysis.
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
- Two cardiac biopsies (50 - 200 mg) will be collected pre-bypass and post- bypass and will be analyzed for gene and protein expression.
- 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.
- rIP induced changes in leukocyte gene expression will be measured at the aforementioned time points.
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.
- qRT-PCR will be used to measure gene expression.
- Immunoblotting will be used to measure protein expression
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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|
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546390
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2G3|
|Principal Investigator:||Barry A Finegan, MB||University of Alberta|