Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

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

Detailed Description
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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.

Official Title
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The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Procedure: Post conditioning
* Procedure: Usual Care for STEMI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post conditioning<br>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. | Procedure: Post conditioning<br>* 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.<br>|
| Active Comparator: Usual Care<br>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. | Procedure: Usual Care for STEMI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software |  | 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. |  | 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. |  | baseline, every 8 hours x 3 | 
| ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3. |  | baseline, up to 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST segment elevation myocardial infarction (STEMI), timed balloon inflations, post conditioning