Restoring microvascular circulation with diagnostic ultrasound and contrast agent: rationale and design of the REDUCE trial - 16/08/24

Doi : 10.1016/j.ahj.2024.06.008

Prajith Jeyaprakash, Bmed, MD, MMed ^a,^b, Faraz Pathan, MBBS, PhD ^a,^b,^c, Koya Ozawa, MD, PhD ^a,^b, Kristy P. Robledo, PhD ^d, Karan K Shah, MSc ^d, Rachael L. Morton, PhD ^d, Christopher Yu, MBBS ^a,^b, Christine Madronio, MPH, MPhil ^a, Hisham Hallani, MBBS ^a,^b, Han Loh, MBBS ^c, Andrew Boyle, MBBS, PhD ^e,^f, Thomas J. Ford, MBBS, PhD ^f,^g, Thomas R. Porter, MD, PhD ^h, Kazuaki Negishi, MD, PhD, MSc ^a,^b,^⁎
^a Faculty of Medicine and Health, Charles Perkins Centre Nepean, Sydney Medical School Nepean, The University of Sydney, New South Wales, Australia
^b Department of Cardiology, Nepean Hospital, Sydney, New South Wales, Australia
^c Department of Radiology, Nepean Hospital, Sydney, New South Wales, Australia
^d NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia
^e Department of Cardiology, John Hunter Hospital, Newcastle, New South Wales, Australia
^f University of Newcastle, New South Wales, Australia
^g Department of Cardiology, Gosford Public Hospital, Gosford, New South Wales, Australia
^h Department of Internal Medicine, Division of Cardiovascular Medicine, University of Nebraska Medical Center, Omaha, NE

^⁎Reprint requests: Kazuaki Negishi, MD, PhD, MSc, FRACP, FACC, FESC, FASE, FAHA, Department of Cardiology, The University of Sydney, Nepean Clinical School, Level 5, South Block, PO Box 63, Penrith, NSW, 2751.Department of CardiologyThe University of SydneyNepean Clinical SchoolLevel 5South BlockPO Box 63PenrithNSW2751

Abstract

Objectives

This study aims to evaluate the efficacy and cost-effectiveness of sonothrombolysis delivered pre and post primary percutaneous coronary intervention (pPCI) on infarct size assessed by cardiac MRI, in patients presenting with STEMI, when compared against sham procedure.

Background

More than a half of patients with successful pPCI have significant microvascular obstruction and residual infarction. Sonothrombolysis is a therapeutic use of ultrasound with contrast enhancement that may improve microcirculation and infarct size. The benefits and real time physiological effects of sonothrombolysis in a multicentre setting are unclear.

Methods

The REDUCE (Restoring microvascular circulation with diagnostic ultrasound and contrast agent) trial is a prospective, multicentre, patient and outcome blinded, sham-controlled trial. Patients presenting with STEMI will be randomized to one of 2 treatment arms, to receive either sonothrombolysis treatment or sham echocardiography before and after pPCI. This tailored design is based on preliminary pilot data from our centre, showing that sonothrombolysis can be safely delivered, without prolonging door to balloon time. Our primary endpoint will be infarct size assessed on day 4±2 on Cardiac Magnetic Resonance (CMR). Patients will be followed up for 6 months post pPCI to assess secondary endpoints. Sample size calculations indicate we will need 150 patients recruited in total.

Conclusions

This multicentre trial will test whether sonothrombolysis delivered pre and post primary PCI can improve patient outcomes and is cost-effective, when compared with sham ultrasound delivered with primary PCI. The results from this trial may provide evidence for the utilization of sonothrombolysis as an adjunct therapy to pPCI to improve cardiovascular outcomes in STEMI. ANZ Clinical Trial Registration number: ACTRN 12620000807954

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Abbreviations : CMR, MI, MSI, MVO, pPCI, RCT, STEMI, STL

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Vol 275

P. 163-172 - septembre 2024 Retour au numéro

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Restoring microvascular circulation with diagnostic ultrasound and contrast agent: rationale and design of the REDUCE trial - 16/08/24

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