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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: May 2010
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.
- 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
- 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
- Onset of symptoms within 6 hours
- TIMI 0 to TIMI 1 flow in infarct related artery
- collaterals to infarct related artery
- previous infarct in related territory
- cardiogenic shock
- TIMI 2 to TIMI 3 flow
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Cincinnati
- 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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