An observational study in ST Elevation Myocardial Infarction, Acute Myocardial Infarction and Coronary Artery Disease, sponsored by Erasmus Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Erasmus Medical Center · Observational
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:
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 200 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting with ST-elevation myocardial infarction eligible for primary percutaneous coronary intervention.
Exclusion Criteria:
Prospective, single arm, observational
Target Vessel Failure (TVF)
A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
Time frame: 12 Months
IVUS-guided optimization
Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI
Time frame: Procedural
TVF
A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
Time frame: 30 Days
Major Adverse Cardiovascular Events (MACE)
A composite of all-cause mortality, any myocardial infarction and repeat revascularization
Time frame: 30 Days
Major Adverse Cardiovascular Events (MACE)
A composite of all-cause mortality, any myocardial infarction and repeat revascularization
Time frame: 12 Months
Individual Components of TVF and MACE
Individual components of the composite endpoints
Time frame: 30 Days
Individual Components of TVF and MACE
Individual components of the composite endpoints
Time frame: 12 months
Major Intraprocedural Complications
Including type C-F dissections, perforations, slow flow or no-reflow, major side branch occlusion (\> 2 mm)
Time frame: Procedural
Angiographic Endpoints
Including final TIMI flow and final myocardial blush grade
Time frame: Procedural
IVUS endpoints (continuous)
At least the following continuous variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks: * Minimal lumen area * Thrombus containing frames * Thrombus maximum angle * Minimal stent area Structured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software.
Time frame: Procedural
IVUS endpoints (categorical)
At least the following categorical variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks: * Plaque rupture * Convex calcium (nodule) * Thrombus type * Plaque type * Thrombus protrusion * Underexpansion * Edge dissection * Hematoma * High plaque burden at stent edges * Residual focal lesion * Malapposition Structured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software.
Time frame: Procedural
Plan to share: No
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center