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.
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.
Study Type
OBSERVATIONAL
Enrollment
200
Erasmus University Medical Center
Rotterdam, Netherlands
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
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