Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI.
Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI. We will also test the hypotheses that IP diminishes the inflammatory response to PCI, and that higher baseline blood endothelial progenitor cell counts are predictive of a favorable response to IP. Aim 1: To evaluate whether remote ischemic preconditioning reduces the frequency of myonecrosis (troponin T≥0.03 ng/ml following PCI). Aim 2: To evaluate whether remote ischemic preconditioning reduces the inflammatory response to PCI (post PCI hsCRP level). Aim 3: To evaluate whether pre-procedure circulating endothelial progenitor cell counts correlate with the effect of remote ischemic preconditioning on myonecrosis. Background: Percutaneous coronary intervention (PCI) frequently results in ischemic myonecrosis. Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI. Aims: The aims of the study are to assess in patients with coronary artery disease requiring PCI, whether remote IP reduces: 1) the frequency of myonecrosis; and 2) the inflammatory response to PCI; and 3) whether the effect of IP correlates with pre-procedure circulating endothelial progenitor cell counts. Methods: The study is a prospective, randomized trial to assess the efficacy of remote IP as adjunctive non-pharmacological therapy for PCI in patients with stable or unstable angina. Remote IP will be performed by 3 cycles of 3-minutes of arm ischemia alternating with 3- minutes of reperfusion of the arm immediately before PCI. Myonecrosis and inflammation will be detected by measuring serum troponin T and high sensitivity C-reactive protein, respectively. Blood EPC counts will also be measured before the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
156
Arm ischemia will be induced using a blood pressure cuff that will be placed around the upper part of the arm, and inflated to 200 mm Hg for 3-minutes and then deflated for 3-minutes
3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia
Mayo Clinic
Rochester, Minnesota, United States
Post PCI myonecrosis measured as a maximum troponin T ≥0.03
Time frame: 16 hours post PCI
Post PCI myonecrosis measured as an elevation in creatine kinase MB fraction (CK-MB> 1 X upper limit of normal)
Time frame: 16 hours post procedure
Magnitude of ST segment elevation on an intracoronary electrocardiogram during balloon inflation
Time frame: During PCI procedure
Coronary perfusion measured as coronary flow reserve derived from TIMI frame counts
Time frame: During PCI
Blood high sensitivity C-reactive protein level
Time frame: Immediately prePCI
Blood endothelial progenitor cell counts (EPC)
Time frame: Immediately prePCI
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