The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
Trial Snapshot
- Phase
- Phase 1
- Status
- Suspended
- Sponsor
- University of Cincinnati
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Tarek Helmy
Professor
University of Cincinnati