Clinical trial NCT00588042: Remote Myocardial Ischemic Preconditioning in Humans
Official title: Remote Myocardial Ischemic Preconditioning in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Ischemia
Keywords: Angioplasty, Transluminal, Percutaneous Coronary
Coronary Artery Disease
Coronary Occlusion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post PCI myonecrosis measured as a maximum troponin T ≥0.03
timeFrame: 16 hours post PCI
Secondary outcomes:
measure: Post PCI myonecrosis measured as an elevation in creatine kinase MB fraction (CK-MB> 1 X upper limit of normal)
timeFrame: 16 hours post procedure
measure: Magnitude of ST segment elevation on an intracoronary electrocardiogram during balloon inflation
timeFrame: During PCI procedure
measure: Coronary perfusion measured as coronary flow reserve derived from TIMI frame counts
timeFrame: During PCI
measure: Blood high sensitivity C-reactive protein level
timeFrame: Immediately prePCI
measure: Blood endothelial progenitor cell counts (EPC)
timeFrame: Immediately prePCI
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Abhiram Prasad, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.