An interventional study of Blood pressure cuff and blood pressure cuff in Coronary Artery Ischemia, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 156 is above the median of 80 across 1,359 interventional studies indexed under Ischemia.
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Patients will be eligible for randomization if they meet the following criteria:
Exclusion Criteria:
Patients will be ineligible for the study if one or more of the following conditions exist:
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
Device: Blood pressure cuff
3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia
Device: blood pressure cuff
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
Also known as: sphygmomanometer
3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia
Also known as: sphygmomanometer
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
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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