Expired Study
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Rochester, Minnesota 55905


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients will be eligible for randomization if they meet the following criteria: 1. Age ≥ 18 years 2. Clinically indicated elective or urgent PCI Exclusion Criteria: - Patients will be ineligible for the study if one or more of the following conditions exist: 1. Pre-PCI Troponin T ≥ 0.03 2. Systemic hypotension (systolic <90 mmHg) or cardiogenic shock 3. Presence of an arteriovenous fistula or lymphedema of either arm 4. Currently enrolled in other active cardiovascular investigational studies 5. Severe endocrine, hepatic, renal, disorders 6. Pregnancy or lactation 7. Inability to provide consent 8. Federal Medical Center inmates 9. Inability or unwillingness to provide informed consent


NCT ID:

NCT00588042


Primary Contact:

Principal Investigator
Abhiram Prasad, MBBS
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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