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| Name | Class |
|---|---|
| Acist Medical Systems | INDUSTRY |
| MicroPort CRM | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD-IVUS-guided primary PCI | Prospective, single arm, observational |
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| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization | 12 Months |
| IVUS-guided optimization | Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI | Procedural |
| Measure | Description | Time Frame |
|---|---|---|
| TVF | A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization | 30 Days |
| Major Adverse Cardiovascular Events (MACE) | A composite of all-cause mortality, any myocardial infarction and repeat revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting with ST-elevation myocardial infarction eligible for primary percutaneous coronary intervention.
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| Name | Affiliation | Role |
|---|---|---|
| Joost Daemen, MD PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center | Rotterdam | 3015GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37232425 | Derived | Groenland FTW, Ziedses des Plantes AC, Neleman T, Scoccia A, Ligthart JMR, Witberg KT, Mahmoud KD, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Van Mieghem NM, Daemen J. Culprit lesion plaque characterization and thrombus grading by high-definition intravascular ultrasound in patients with ST-segment elevation myocardial infarction. Catheter Cardiovasc Interv. 2023 Aug;102(2):191-199. doi: 10.1002/ccd.30699. Epub 2023 May 26. | |
| 35437257 |
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| 30 Days |
| Major Adverse Cardiovascular Events (MACE) | A composite of all-cause mortality, any myocardial infarction and repeat revascularization | 12 Months |
| Individual Components of TVF and MACE | Individual components of the composite endpoints | 30 Days |
| Individual Components of TVF and MACE | Individual components of the composite endpoints | 12 months |
| Major Intraprocedural Complications | Including type C-F dissections, perforations, slow flow or no-reflow, major side branch occlusion (> 2 mm) | Procedural |
| Angiographic Endpoints | Including final TIMI flow and final myocardial blush grade | Procedural |
| IVUS endpoints (continuous) | At least the following continuous variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks:
Structured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software. | Procedural |
| IVUS endpoints (categorical) | At least the following categorical variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks:
Structured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software. | Procedural |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016769 | Embolism and Thrombosis |
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