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Remote Myocardial Ischemic Preconditioning in Humans (RemoteMIPH)
This study is currently recruiting participants.
Verified by Mayo Clinic, May 2008
First Received: December 21, 2007   Last Updated: May 20, 2008   History of Changes
Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588042
  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.


Condition Intervention
Coronary Artery Ischemia
 Device: Blood pressure cuff
Device: blood pressure cuff

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Remote Myocardial Ischemic Preconditioning in Humans

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Post PCI myonecrosis measured as a maximum troponin T ≥0.03 [ Time Frame: 16 hours post PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Magnitude of ST segment elevation on an intracoronary electrocardiogram during balloon inflation [ Time Frame: During PCI procedure ] [ Designated as safety issue: No ]
  • Coronary perfusion measured as coronary flow reserve derived from TIMI frame counts [ Time Frame: During PCI ] [ Designated as safety issue: No ]
  • Blood high sensitivity C-reactive protein level [ Time Frame: Immediately prePCI ] [ Designated as safety issue: No ]
  • Blood endothelial progenitor cell counts (EPC) [ Time Frame: Immediately prePCI ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: October 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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
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: Sham Comparator
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
3-cycles of cuff inflation (10 mmHg)-deflation will also be performed in the control group for similar durations without inducing ischemia

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588042

Contacts
Contact: Abhiram Prasad, M.D. 507-255-6092 prasad.abhiram@mayo.edu
Contact: Lynn E. Polk, R.N. 507-255-2527 polk.lynn@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Abhiram Prasad, M.D.     507-255-6092     prasad.abhiram@mayo.edu    
Contact: Lynn E. Polk, R.N.     507-255-2527     polk.lynn@mayo.edu    
Principal Investigator: Abhiram Prasad, M.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Abhiram Prasad, MBBS Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mayo Clinic ( Abhiram Prasad, M.D. )
Study ID Numbers: 06-005081, Remote MIPH
Study First Received: December 21, 2007
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00588042     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Artery Disease
Coronary Occlusion

Study placed in the following topic categories:
Coronary Occlusion
Coronary Disease
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Pathologic Processes
Ischemia

ClinicalTrials.gov processed this record on May 07, 2009



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