Clinical trial
Effect of Diagnostic Echocardiogram on Microvascular Recovery Following Acute STEMI
Name
0300-17-FB
Description
The investigators propose to test the effectiveness of a technique that uses a modified commercially available ultrasound system used for cardiac imaging, and a commercially available ultrasound contrast agent (microbubbles) to break up the blood clots that cause heart attacks. The ultrasound and microbubbles will be applied as soon as possible to patients presenting to the emergency department, after an EKG confirms that a heart attack is ongoing. Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the small branches (capillaries) that are fed by this artery. Following the randomized treatment, patients will be followed for the development of any complications (recurrent heart attack, heart failure, or need for defibrillator placement) as well as by echo and cardiac MRI to determine how much heart muscle was salvaged by the treatment.
Trial arms
Trial start
2018-09-16
Estimated PCD
2023-03-03
Trial end
2023-09-03
Status
Completed
Treatment
percutaneous intervention (PCI)
Successful PCI with the patent vessel and at least Thrombolysis in Myocardial Infarction (TIMI) 2 flow in the left anterior descending artery (LAD) post-PCI.
Arms:
Standard of care, Ultrasound and microbubbles
Microbubbles
The agents will be divided into two separate doses (two vials per study), and mixed with approximately 29 milliliters of saline (approximately a 2.0-4.0% infusion). The first dilution will be administered pre PCI therapy, and the second dilution infused immediately post PCI. Since Optison is less stable in saline, an alternative approach will be to give the Optison as intermittent 0.1 milliliter boluses followed by 3-5 saline flushes over 10 seconds. The entire duration of each treatment before PCI will be up to 30 minutes depending on time constraints in getting to the catheterization laboratory, while the duration of treatment immediately after PCI will be 30 minutes.
Arms:
Ultrasound and microbubbles
Other names:
DEFINITY® (Perflutren Lipid Microsphere) manufactured by Lantheus Medical Imaging, OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) manufactured by General Electric Global Research
Ultrasound
Intermittent high Mechanical Index (MI) impulses (0.8-1.4 MI; Frequency 1.0-1.7 MegaHertz (MHz); pulse duration 4-44 microseconds) will be administered over the microvasculature where there are wall motion abnormalities and a perfusion defect using an imaging plane that best aligns itself with the risk area
Arms:
Ultrasound and microbubbles
Size
50
Primary endpoint
Six month event free survival (EFS)
6 months
Myocardial salvageability index
Prior to hospital discharge (48-72 hours)
Frequency of left ventricular remodeling
6 month follow-up
Eligibility criteria
Inclusion Criteria:
* Patients presenting to participating centers with chest pain and EKG evidence of an acute STEMI (two contiguous leads with \>0.1 millivolt (mV) ST elevation or \>0.1 ST depression in V2-V4) will be asked to participate. The inclusion criteria will be:
1. Age ≥30 years.
2. Eligible for emergent PCI/antithrombotic/antiplatelet therapy.
3. Adequate apical and/or parasternal images by echocardiography.
4. No contraindications or hypersensitivities to ultrasound contrast agents.
Exclusion Criteria:
1. Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
2. Cardiogenic Shock
3. Life expectancy of less than two months or terminally ill.
4. Known severe cardiomyopathy.
5. Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin
6. Known large right to left intracardiac shunts.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-10-31
1 organization
1 product
2 indications
Organization
University of NebraskaProduct
MicrobubblesIndication
STEMIIndication
Chest Pain