Remote Myocardial Ischemic Preconditioning in Humans

NCT ID: NCT00588042

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Coronary Artery Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Blood pressure cuff

Intervention Type: DEVICE

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

2

3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia

Group Type: SHAM_COMPARATOR

blood pressure cuff

Intervention Type: DEVICE

3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

sphygmomanometer; sphygmomanometer

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Abhiram Prasad

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abhiram Prasad, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Prasad A, Gossl M, Hoyt J, Lennon RJ, Polk L, Simari R, Holmes DR Jr, Rihal CS, Lerman A. Remote ischemic preconditioning immediately before percutaneous coronary intervention does not impact myocardial necrosis, inflammatory response, and circulating endothelial progenitor cell counts: a single center randomized sham controlled trial. Catheter Cardiovasc Interv. 2013 May;81(6):930-6. doi: 10.1002/ccd.24443. Epub 2012 Nov 8.

Reference Type: RESULT

PMID: 22517646 (View on PubMed)

Other Identifiers

06-005081

Identifier Type: -

Identifier Source: org_study_id