Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

Phase 1

Suspended

• Conditions: Acute Myocardial Infarction
• Interventions: Procedure: Post conditioning; Procedure: Usual Care for STEMI

• Registration Number: NCT00846378
• Lead Sponsor: University of Cincinnati

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Primary Completion: 2010-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post conditioning	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.
Usual Care	Usual Care for STEMI	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States