Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    200
  • sponsor
    Erasmus Medical Center
Updated on 22 August 2021
clot
myocardial infarction
stemi
infarct
percutaneous coronary intervention
intravascular ultrasound
blood clot

Summary

This prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (HD-IVUS) as guidance for primary percutaneous coronary intervention (PCI) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with ST-elevation myocardial infarction (STEMI).

Objectives
  • To assess clinical outcomes after IVUS-guided primary PCI in STEMI patients.
  • To assess IVUS-guided optimization in STEMI patients.
  • To assess culprit lesion plaque characteristics in STEMI patients with HD-IVUS.
  • To assess and quantify thrombus in STEMI patients with HD-IVUS.
  • To explore HD-IVUS derived predictors for clinically relevant aspiration thrombectomy.

Description

The SPECTRUM study is an investigator-initiated, single-center, prospective, single arm, observational cohort study investigating the safety and efficacy of (HD)-IVUS as guidance for primary PCI in 200 patients with STEMI. This study enables the assessment of culprit lesion plaque characteristics and thrombus morphology with a 40-60 MHz HD-IVUS catheter.

All study patients will have a protocolized pre-intervention IVUS pullback directly after recanalization (so before any lesion preparation, i.e. balloon dilatation, aspiration thrombectomy or stent placement) and a post-intervention IVUS pullback. Subsequently, if IVUS-guided optimization is performed, a final pullback is highly recommended and considered as the post-optimization IVUS pullback.

The primary study outcomes are target vessel failure at 12 months and incidence of IVUS-guided optimization. More information on outcome measures is provided in the section below.

Details
Condition Myocardial Ischemia, Heart Attack (Myocardial Infarction), Acute Myocardial Infarction, Thrombosis, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention, Myocardial Infarction, Intravascular Ultrasound, STEMI, blood clot, blood clotting, Coronary heart disease, Blood Clots, Cardiac Ischemia, clot, Coronary Artery Disease
Clinical Study IdentifierNCT05007535
SponsorErasmus Medical Center
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Native coronary artery culprit lesion, angiographically
Culprit vessel reference diameter 2.25 mm, angiographically

Exclusion Criteria

Cardiogenic shock
Presentation > 12 hours after symptom onset
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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