Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

University of Cincinnati30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Myocardial Infarction

Interventions

Post conditioningPROCEDURE

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.

Usual Care for STEMIPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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