Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: Rationale and design of the SPECTRUM study

Frederik T.W. Groenland, Karim D. Mahmoud, Tara Neleman, Annemieke C. Ziedses Des Plantes, Alessandra Scoccia, Jurgen Ligthart, Karen T. Witberg, Rutger Jan Nuis, Wijnand K. Den Dekker, Jeroen M. Wilschut, Roberto Diletti, Felix Zijlstra, Isabella Kardys, Paul Cummins, Nicolas M. Van Mieghem, Joost Daemen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Introduction Intravascular ultrasound (IVUS) improves clinical outcome in patients undergoing percutaneous coronary intervention (PCI) but dedicated prospective studies assessing the safety and efficacy of IVUS guidance during primary PCI are lacking. Methods and analysis The SPECTRUM study is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enrol 200 patients presenting with ST-segment elevation myocardial infarct undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, postintervention and postoptimisation (if applicable), using a 40-60 MHz high-definition (HD) system. Baseline tissue characterisation includes the morphological description of culprit lesion plaque characteristics and thrombus as assessed with HD-IVUS. The primary endpoint is target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation). The secondary outcome of interest is IVUS-guided optimisation, defined as IVUS-guided additional balloon dilatation or stent placement. Other endpoints include clinical and procedural outcomes along with post-PCI IVUS findings. Ethics and dissemination The protocol of this study was approved by the Ethics Committee of the Erasmus University Medical Center, Rotterdam, the Netherlands. Written informed consent is obtained from all patients. Study findings will be submitted to international peer-reviewed journals in the field of cardiovascular imaging and interventions and will be presented at international scientific meetings.

Original languageEnglish
Article numbere001955
JournalOpen Heart
Volume9
Issue number1
DOIs
Publication statusPublished - 18 Apr 2022

Bibliographical note

Funding Information:
The SPECTRUM study is an investigator-initiated study sponsored by the Erasmus University Medical Center, Rotterdam, the Netherlands. This work was supported by by ACIST Medical Systems, Eden Prairie, Minnesota, USA, and Microport, Shanghai, China.

Funding Information:
Competing interests JD received institutional grant/research support from Abbott Vascular, ACIST Medical, Astra Zeneca, Boston Scientific, Medtronic, Microport, Pie Medical and ReCor Medical. Nicolas Van Mieghem received institutional research grant support from Abbott Vascular, Abiomed, Boston Scientific, Daiichi-Sankyo, Edward Lifesciences, Medtronic, and PulseCath. Roberto Diletti is consultant to ACIST Medical. JL received speaking fees from Boston Scientific, Philips Volcano, ACIST Medical, Abbott Vascular and Pie Medical.

Publisher Copyright:
© 2022 Author(s). Published by BMJ.

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