Clinical trial NCT05974930: Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction
Official title: Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction: the ULTRA-STEMI Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: STEMI
Intravascular Imaging
IVUS
Keywords: IVUS
Thrombus
STEMI
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients presenting with STEMI undergoing primary PCI for a native coronary artery culprit lesion will undergo IVUS (at baseline, post-intervention and post-optimization) and post-PCI iFR.

Brief summary: The main goal of the ULTRA-STEMI trial is to investigate the prognostic impact of IVUS-guided PCI in patients with STEMI and correlate IVUS measurements with clinical, procedural, imaging and follow-up outcomes of interest.

Study participants will undergo primary PCI as per standardized procedures; IVUS will be performed at baseline, post-intervention and post-optimization. Manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT). Also, angiographic and peri-procedural data will be gathered. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least12 months for the adjudication of major adverse cardiovascular events.

Detailed description: The ULTRA-STEMI trial is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enroll 80 consecutive patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, post-intervention and post-optimization. Baseline tissue characterization includes the morphological description of culprit lesion plaque and thrombus characteristics as assessed with IVUS. In patients with large thrombus burden, manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT) to correlate IVUS measurements with micro-CT thrombus quantification. Also, angiographic data will be gathered to correlate IVUS measurements with pre-and post-PCI angiographic information. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least 12 months for the adjudication of major adverse cardiovascular events.The primary endpoint will be target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization). The secondary outcomes of interest will be: radiation exposure, contrast use and kidney function effects. Other endpoints include clinical and angiographic outcomes along with post-PCI IVUS, iFR and micro-CT findings.

Eligibility criteria: Inclusion Criteria:

1. Patients with acute STEMI undergoing primary PCI within 12 hours of symptom onset according to the 4th universal definition of myocardial infarction.
2. Age \>18 years
3. Individuals willing to voluntarily sign the consent and data protection forms before their inclusion in the clinical study.

Exclusion Criteria:

1. Patients presenting with cardiogenic shock
2. Patients with a known contraindication for primary PCI
3. Pregnancy
4. Presentation ≥12 hours after symptom onset

Primary outcomes:
measure: Rate of "Target vessel failure" at 12 months of follow-up in association with IVUS measurements
timeFrame: 2 years
measure: All-cause mortality at 12 months of follow-up in association with IVUS measurements
timeFrame: 2 years
Secondary outcomes:
measure: In-hospital (post-PCI) adverse events in association with IVUS measurements
timeFrame: 2 years
measure: Pre-procedural angiographic outcomes in association with IVUS measurements
timeFrame: 2 years
measure: Post-procedural angiographic outcomes in association with IVUS measurements
timeFrame: 2 years
measure: Post-PCI iFR measurement in association with IVUS measurements
timeFrame: 2 years
measure: Microtomographic thrombus volume in association with IVUS measurements
timeFrame: 2 years
measure: Microtomographic thrombus porosity in association with IVUS measurements
timeFrame: 2 years
measure: Microtomographic thrombus density in association with IVUS measurements
timeFrame: 2 years
measure: Νumber and type of stents in association with IVUS measurements
timeFrame: 2 years
measure: Stent length and diameter in association with IVUS measurements
timeFrame: 2 years
measure: Contrast volume in association with IVUS measurements
timeFrame: 2 years
measure: Radiation dose in association with IVUS measurements
timeFrame: 2 years
measure: Procedural duration in association with IVUS measurements
timeFrame: 2 years
measure: Post-PCI stent underexpansion, deformation or malapposition in association with baseline IVUS measurements
timeFrame: 2 years
measure: Post-PCI edge dissection in association with baseline IVUS measurements
timeFrame: 2 years
measure: Post-PCI high plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts in association with baseline IVUS measurements
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: 2ND Cardiology Department, Hippokrateion General Hospital of Thessaloniki, Greece
name: Georgios Kassimis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Groenland FTW, Mahmoud KD, Neleman T, Ziedses des Plantes AC, Scoccia A, Ligthart J, Witberg KT, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Kardys I, Cummins P, Van Mieghem NM, Daemen J. Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study. Open Heart. 2022 Apr;9(1):e001955. doi: 10.1136/openhrt-2021-001955.
citation: Karagiannidis E, Papazoglou AS, Sofidis G, Chatzinikolaou E, Keklikoglou K, Panteris E, Kartas A, Stalikas N, Zegkos T, Girtovitis F, Moysidis DV, Stefanopoulos L, Koupidis K, Hadjimiltiades S, Giannakoulas G, Arvanitidis C, Michaelson JS, Karvounis H, Sianos G. Micro-CT-Based Quantification of Extracted Thrombus Burden Characteristics and Association With Angiographic Outcomes in Patients With ST-Elevation Myocardial Infarction: The QUEST-STEMI Study. Front Cardiovasc Med. 2021 Apr 21;8:646064. doi: 10.3389/fcvm.2021.646064. eCollection 2021.
citation: Didagelos M, Pagiantza A, Zegkos T, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Kassimis G, Karvounis H, Ziakas A. Low Molecular Weight Heparin in Improving RAO After Transradial Coronary Catheterization: The LOW-RAO Randomized Study. JACC Cardiovasc Interv. 2022 Aug 22;15(16):1686-1688. doi: 10.1016/j.jcin.2022.05.047. Epub 2022 Jul 27. No abstract available.