RT Journal Article
SR Electronic
T1 Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study
JF Open Heart
JO Open Heart
FD British Cardiovascular Society
SP e001955
DO 10.1136/openhrt-2021-001955
VO 9
IS 1
A1 Groenland, Frederik T W
A1 Mahmoud, Karim D
A1 Neleman, Tara
A1 Ziedses des Plantes, Annemieke C
A1 Scoccia, Alessandra
A1 Ligthart, Jurgen
A1 Witberg, Karen T
A1 Nuis, Rutger-Jan
A1 den Dekker, Wijnand K
A1 Wilschut, Jeroen M
A1 Diletti, Roberto
A1 Zijlstra, Felix
A1 Kardys, Isabella
A1 Cummins, Paul
A1 Van Mieghem, Nicolas M
A1 Daemen, Joost
YR 2022
UL http://openheart.bmj.com/content/9/1/e001955.abstract
AB 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.Trial registration number NCT05007535.Data sharing not applicable as no datasets generated and/or analysed for this study protocol.