Clinical trial NCT00955136: Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes
Official title: Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Keywords: ST elevated myocardial infarction
Acute coronary syndrome
MRX 801
Echocardiography
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Microvascular Therapeutics, LLC
name: The Ruth and Bruce Rappaport Faculty of Medicine
name: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
name: InCor Heart Institute
name: Bnai Zion Medical Center
First posted: 2009-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.

Detailed description: Pre-clinical studies have indicated that, during a continuous infusion of intravenous perfluorocarbon-containing microbubbles, the ultrasonic power delivered from a diagnostic ultrasound transducer is capable of restoring microcirculatory flow and improving epicardial recanalization rates following acute coronary thrombotic occlusions. Since both diagnostic ultrasound and intravenous infusions of microbubbles are a Class I indication to assess regional and global left ventricular function and risk area in patients with ST segment elevation myocardial infarction (STEMI), this pilot study will examine whether diagnostic assessments of left ventricular function and risk area size impacts epicardial recanalization rates and infarct size in STEMI.

The aim of this study is to test whether guided high mechanical index impulses from a diagnostic transducer during a continuous infusion of intravenous microbubbles are capable of improving microvascular recanalization and epicardial recanalization rates in STEMI, as assessed by coronary angiography, and recovery of regional microvascular perfusion and function in the post-infarction period.

Eligibility criteria: Inclusion Criteria:

1. Male or female, age ≥ 30 years.
2. Chest Pain occurring lasting less than six hours from onset, and EKG evidence of an acute ST segment elevation myocardial infarction.
3. Arrival in the Emergency Department with above inclusion criteria between 7 am and 7pm.

Exclusion Criteria:

1. Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
2. Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
3. Life expectancy of less than two months or terminally ill.
4. Heart transplant recipient, hypertrophic cardiomyopathy, severe valvular disease, acute myo- or pericarditis.
5. Contraindication to Heart Catheterization
6. Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors or aspirin.

Primary outcomes:
measure: Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Thomas R Porter, MD
role: PRINCIPAL_INVESTIGATOR
References: