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Microvascular Reperfusion Utilizing Sonothrombolysis in Acute Myocardial Infarction (MRUSMI TRIAL)

Information source: University of Nebraska
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: STEMI; Chest Pain,

Intervention: percutaneous intervention (PCI) (Procedure); Microbubbles (Drug); Ultrasound (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Nebraska

Official(s) and/or principal investigator(s):
Thomas R Porter, MD, Principal Investigator, Affiliation: University of NE Medical Center

Overall contact:
Thomas R Porter, MD, Phone: 402-559-7977, Email: trporter@unmc.edu

Summary

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. A total of 250 patients will be enrolled and followed at two different sites. Randomization will be stratified at each study site. The initial site enrolling patients will be University of Sao Paulo Medical School. Wilson Mathias, MD, will serve as the principal investigator for this site. The other is VU University Medical Center in Amsterdam, where Otto Kamp, MD, will serve as the principal investigator.

Clinical Details

Official title: Microvascular Reperfusion Utilizing Sonothrombolysis in Acute Myocardial Infarction (MRUSMI TRIAL)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Six month event free survival (EFS)

Myocardial salvageability index

Frequency of left ventricular remodeling

Secondary outcome:

Safety of contrast in this setting

Frequency of > 50% ST segment resolution by EKG at six hours post PCI.

Area under the CPK (Creatine Phosphokinase) versus time curve

Overall survival (OS)

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients presenting to participating centers with chest pain and EKG evidence of an

acute STEMI (two contiguous leads with >0. 1 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.

Locations and Contacts

Thomas R Porter, MD, Phone: 402-559-7977, Email: trporter@unmc.edu

University of Sao Paulo Medical Center, Sao Paulo, Brazil; Recruiting
Wilson Mathias, Jr, MD, Phone: (011) 98415-5556., Email: wmathias@me.com

VU University Medical Center, Amsterdam, Netherlands; Not yet recruiting
Otto Kamp, MD

Additional Information

Related publications:

O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso JE, Tracy CM, Woo YJ, Zhao DX; CF/AHA Task Force. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):529-55. doi: 10.1161/CIR.0b013e3182742c84. Epub 2012 Dec 17.

Eitel I, Desch S, Fuernau G, Hildebrand L, Gutberlet M, Schuler G, Thiele H. Prognostic significance and determinants of myocardial salvage assessed by cardiovascular magnetic resonance in acute reperfused myocardial infarction. J Am Coll Cardiol. 2010 Jun 1;55(22):2470-9. doi: 10.1016/j.jacc.2010.01.049.

European Heart Rhythm Association; Heart Rhythm Society, Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). J Am Coll Cardiol. 2006 Sep 5;48(5):e247-346.

Ross AM, Gibbons RJ, Stone GW, Kloner RA, Alexander RW; AMISTAD-II Investigators. A randomized, double-blinded, placebo-controlled multicenter trial of adenosine as an adjunct to reperfusion in the treatment of acute myocardial infarction (AMISTAD-II). J Am Coll Cardiol. 2005 Jun 7;45(11):1775-80.

Galiuto L, Garramone B, Scarà A, Rebuzzi AG, Crea F, La Torre G, Funaro S, Madonna M, Fedele F, Agati L; AMICI Investigators. The extent of microvascular damage during myocardial contrast echocardiography is superior to other known indexes of post-infarct reperfusion in predicting left ventricular remodeling: results of the multicenter AMICI study. J Am Coll Cardiol. 2008 Feb 5;51(5):552-9. doi: 10.1016/j.jacc.2007.09.051.

Starting date: May 2014
Last updated: June 19, 2014

Page last updated: August 23, 2015

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