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

STEMI Clinical Trial

— ULTRA-STEMI  

Official title:

Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction: the ULTRA-STEMI Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05974930
• Other study ID #: 69589
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: July 2023
• Source: Aristotle University Of Thessaloniki
• Contact: Georgios Kassimis, MD, PhD
• Phone: +306936693916
• Email: gksup[@]yahoo.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Device:
• IVUS imaging for primary PCI guidance
Eagle Eye Platinum Intravascular ultrasound (IVUS) will be used to assess intra-coronary plaque, thrombus or stenosis in patients with STEMI. The device is FDA- and EMA-approved and routinely used in clinical practice. Quantitative and qualitative IVUS parameters will be collected and recorded for all participants to be correlated with clinical, imaging and angiographic outcomes of interest.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of "Target vessel failure" at 12 months of follow-up in association with IVUS measurements	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).	2 years
Primary	All-cause mortality at 12 months of follow-up in association with IVUS measurements	Co-primary study outcome will be the investigation of all-cause mortality (i.e., death from any cause) after hospitalization and during follow-up.	2 years
Secondary	In-hospital (post-PCI) adverse events in association with IVUS measurements	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.	2 years
Secondary	Pre-procedural angiographic outcomes in association with IVUS measurements	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.	2 years
Secondary	Post-procedural angiographic outcomes in association with IVUS measurements	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.	2 years
Secondary	Post-PCI iFR measurement in association with IVUS measurements	iFR=ratio of distal coronary pressure (Pd) to the aortic pressure (Pa) during an isolated period during diastole.	2 years
Secondary	Microtomographic thrombus volume in association with IVUS measurements	Micro-CT derived volume of the extracted thrombotic material will be correlated with IVUS measurements.	2 years
Secondary	Microtomographic thrombus porosity in association with IVUS measurements	Micro-CT derived porosity of the extracted thrombotic material will be correlated with IVUS measurements.	2 years
Secondary	Microtomographic thrombus density in association with IVUS measurements	Micro-CT derived density of the extracted thrombotic material will be correlated with IVUS measurements.	2 years
Secondary	?umber and type of stents in association with IVUS measurements	?umber and type of stents used will be recorded and associated with IVUS measurements.	2 years
Secondary	Stent length and diameter in association with IVUS measurements	Stent length and diameter will be recorded and associated with IVUS measurements.	2 years
Secondary	Contrast volume in association with IVUS measurements	Volume of the contrast used will be recorded and associated with IVUS measurements.	2 years
Secondary	Radiation dose in association with IVUS measurements	Peri-procedural radiation dose will be recorded and associated with IVUS measurements.	2 years
Secondary	Procedural duration in association with IVUS measurements	Procedural duration will be recorded and associated with IVUS measurements.	2 years
Secondary	Post-PCI stent underexpansion, deformation or malapposition in association with baseline IVUS measurements	Stent underexpansion, deformation or malapposition (yes/no) will be recorded and associated with baseline IVUS measurements.	2 years
Secondary	Post-PCI edge dissection in association with baseline IVUS measurements	Edge dissection (yes/no) will be recorded and associated with baseline IVUS measurements.	2 years
Secondary	Post-PCI high plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts in association with baseline IVUS measurements	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.	2 years