Acute Myocardial Infarction
Conditions
Keywords
ST segment elevation myocardial infarction (STEMI), timed balloon inflations, post conditioning
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.
Interventions
PROCEDUREPost 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.
PROCEDUREUsual 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.
Sponsors
Cardiology Research UBC
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed