Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction

Not yet recruiting

• Conditions: STEMI; Intravascular Imaging; IVUS

• Registration Number: NCT05974930
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-25
• Last Update Submitted: 2023-07-25
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Study Start: 2023-10-01
• Primary Completion: 2024-10-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of "Target vessel failure" at 12 months of follow-up in association with IVUS measurements	2 years	Follow-up will be obtained using online patient-reported outcome measurements by email or standardized telephone calls at 30 days, 6 months and 12 months after the procedure. Primary follow-up outcome of interest is the composite endpoint of target vessel failure (cardiac death, new-onset heart failure, target vessel myocardial infarction, clinically driven target vessel revascularization or target lesion revascularization).
All-cause mortality at 12 months of follow-up in association with IVUS measurements	2 years	Co-primary study outcome will be the investigation of all-cause mortality (i.e., death from any cause) after hospitalization and during follow-up.

Secondary Outcome Measures

Name	Time	Method
Post-PCI iFR measurement in association with IVUS measurements	2 years	iFR=ratio of distal coronary pressure (Pd) to the aortic pressure (Pa) during an isolated period during diastole.
Microtomographic thrombus volume in association with IVUS measurements	2 years	Micro-CT derived volume of the extracted thrombotic material will be correlated with IVUS measurements.
Pre-procedural angiographic outcomes in association with IVUS measurements	2 years	Pre-procedural Thrombolysis in myocardial infarction (TIMI) flow, thrombus burden classification, culprit vessel, number of diseased vessels, and the SYNergy between percutaneous intervention with TAXus DES and cardiac surgery (SYNTAX) score will be recorded and associated with pre-procedural IVUS measurements. Higher SYNTAX score and lower TIMI flow represent greater obstruction in the diseased vessels.
Νumber and type of stents in association with IVUS measurements	2 years	Νumber and type of stents used will be recorded and associated with IVUS measurements.
Radiation dose in association with IVUS measurements	2 years	Peri-procedural radiation dose will be recorded and associated with IVUS measurements.
Microtomographic thrombus porosity in association with IVUS measurements	2 years	Micro-CT derived porosity of the extracted thrombotic material will be correlated with IVUS measurements.
Post-PCI stent underexpansion, deformation or malapposition in association with baseline IVUS measurements	2 years	Stent underexpansion, deformation or malapposition (yes/no) will be recorded and associated with baseline IVUS measurements.
In-hospital (post-PCI) adverse events in association with IVUS measurements	2 years	The composite endpoint of in-hospital (post-PCI) adverse events includes: cardiac tamponade, need for CABG, shock, in-hospital mortality, acute kidney failure, bleeding, stroke.
Post-procedural angiographic outcomes in association with IVUS measurements	2 years	Post-procedural TIMI flow, angiographically evident residual thrombus, no-reflow phenomenon, myocardial blush grade, and distal embolization will be recorded and associated with IVUS measurements.
Stent length and diameter in association with IVUS measurements	2 years	Stent length and diameter will be recorded and associated with IVUS measurements.
Procedural duration in association with IVUS measurements	2 years	Procedural duration will be recorded and associated with IVUS measurements.
Post-PCI edge dissection in association with baseline IVUS measurements	2 years	Edge dissection (yes/no) will be recorded and associated with baseline IVUS measurements.
Post-PCI high plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts in association with baseline IVUS measurements	2 years	High plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts (yes/no) will be recorded and associated with baseline IVUS measurements.
Microtomographic thrombus density in association with IVUS measurements	2 years	Micro-CT derived density of the extracted thrombotic material will be correlated with IVUS measurements.
Contrast volume in association with IVUS measurements	2 years	Volume of the contrast used will be recorded and associated with IVUS measurements.