Remote Myocardial Ischemic Preconditioning in Humans

Coronary Artery Ischemia Clinical Trial

— RemoteMIPH  

Official title:

Remote Myocardial Ischemic Preconditioning in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588042
• Other study ID #: 06-005081
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: June 2009

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Ischemia
• Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Prasad A, Gössl 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 end — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post PCI myonecrosis measured as a maximum troponin T =0.03		16 hours post PCI
Secondary	Post PCI myonecrosis measured as an elevation in creatine kinase MB fraction (CK-MB> 1 X upper limit of normal)		16 hours post procedure
Secondary	Magnitude of ST segment elevation on an intracoronary electrocardiogram during balloon inflation		During PCI procedure
Secondary	Coronary perfusion measured as coronary flow reserve derived from TIMI frame counts		During PCI
Secondary	Blood high sensitivity C-reactive protein level		Immediately prePCI
Secondary	Blood endothelial progenitor cell counts (EPC)		Immediately prePCI

External Links

•   Mayo Clinic Clinical Trials