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

NCT05974930 | Unknown FDA Device

• 1 other identifier: 69589
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

STEMI; Intravascular Imaging; IVUS

Keywords

IVUS; Thrombus; STEMI

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (15)

• In-hospital (post-PCI) adverse events in association with IVUS measurements

  2 years

• Pre-procedural angiographic outcomes in association with IVUS measurements

  2 years

• Post-procedural angiographic outcomes in association with IVUS measurements

  2 years

• Post-PCI iFR measurement in association with IVUS measurements

  2 years

• Microtomographic thrombus volume in association with IVUS measurements

  2 years

Study Arms (1)

Patients with STEMI undergoing IVUS-guided primary PCI

The ULTRA-STEMI trial will include consecutive patients with STEMI undergoing IVUS-guided primary PCI. All participants will undergo: IVUS intra-coronary imaging at baseline-, post-intervention and post-optimization. If manual thrombus aspiration is needed, the aspirated thrombotic material will be collected to be micro-CT scanned. Post-PCI iFR will be also performed in each participant. Clinical, angiographic and peri-procedural data will be collected. Each participant will be subject to telephone follow-up at 1, 6 and 12 months.

Device: IVUS imaging for primary PCI guidance

Interventions

IVUS imaging for primary PCI guidance DEVICE

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.

Patients with STEMI undergoing IVUS-guided primary PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with acute STEMI undergoing primary PCI within 12 hours of symptom onset according to the 4th universal definition of myocardial infarction.
• Age \>18 years

You may not qualify if:

• Patients presenting with cardiogenic shock
• Patients with a known contraindication for primary PCI
• Pregnancy
• Presentation ≥12 hours after symptom onset

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Related Publications (3)

• 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.

  PMID: 35437257 BACKGROUND

• 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.

  PMID: 33969012 BACKGROUND

• 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.

  PMID: 35981848 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Aspirated thrombotic samples (in cases with large thrombus burden) will be collected to undergo micro-CT scanning.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Thrombosis

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Study Officials

• Georgios Kassimis, MD, PhD

  2ND Cardiology Department, Hippokrateion General Hospital of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Kassimis, MD, PhD

CONTACT

+306936693916; gksup@yahoo.gr

Efstratios Karagiannidis, MD, PhD

CONTACT

+306938943309; stratoskarag@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 3, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 30, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-07