Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

Overview

The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.

Full Title of Study: “The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2010

Detailed Description

The intervention of "post conditioning" at the time of reperfusion, in patients with acute myocardial infarction (AMI), will attenuate the degree of ischemia-reperfusion injury, as manifested by infarct size. This intervention is hypothesized to be safe in humans.

Interventions

  • Procedure: Post conditioning
    • after 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
  • Procedure: Usual Care for STEMI
    • Usual care for treatment of TIMI 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.

Arms, Groups and Cohorts

  • Experimental: Post conditioning
    • After 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. The balloon should be inflated to only occlude the coronary artery. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
  • Active Comparator: Usual Care
    • Usual care for treatment of thrombolysis in myocardial infarction (TIMI) 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.

Clinical Trial Outcome Measures

Primary Measures

  • Quantitation of infarct size will be done using a modification of University Hospital’s standard Single-photon emission computed tomography (SPECT) quantitation software
    • Time Frame: 6 weeks
  • Echocardiograms will be analyzed to evaluate left ventricular function. Standard techniques will be used to quantitate ejection fraction and the percentage of left ventricular circumference that is hypokinetic or dyskinetic.
    • Time Frame: 6 weeks
  • Venous blood samples troponin, creatine phosphokinase (CPK). This will be done to follow enzyme release and washout, and area data will be available and infarct size/risk area ratios in control and post-conditioning subjects will be compared.
    • Time Frame: baseline, every 8 hours x 3
  • ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3.
    • Time Frame: baseline, up to 3 days

Participating in This Clinical Trial

Inclusion Criteria

  • STEMI
  • Onset of symptoms within 6 hours
  • TIMI 0 to TIMI 1 flow in infarct related artery

Exclusion Criteria

  • collaterals to infarct related artery
  • previous infarct in related territory
  • thrombolytics
  • cardiogenic shock
  • TIMI 2 to TIMI 3 flow

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Cincinnati
  • Collaborator
    • Cardiology Research UBC
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tarek Helmy, Professor – University of Cincinnati
  • Overall Official(s)
    • Tarek Helmy, MD, Principal Investigator, University of Cincinnati

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