Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction: the ULTRA-STEMI Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Rate of "Target vessel failure" at 12 months of follow-up in association with IVUS measurements
研究概览
简要总结
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.
详细描述
The ULTRA-STEMI trial is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enroll 80 consecutive patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, post-intervention and post-optimization. Baseline tissue characterization includes the morphological description of culprit lesion plaque and thrombus characteristics as assessed with IVUS. In patients with large thrombus burden, manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT) to correlate IVUS measurements with micro-CT thrombus quantification. Also, angiographic data will be gathered to correlate IVUS measurements with pre-and post-PCI angiographic information. 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 least 12 months for the adjudication of major adverse cardiovascular events.The primary endpoint will be target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization). The secondary outcomes of interest will be: radiation exposure, contrast use and kidney function effects. Other endpoints include clinical and angiographic outcomes along with post-PCI IVUS, iFR and micro-CT findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Individuals willing to voluntarily sign the consent and data protection forms before their inclusion in the clinical study.
排除标准
- •Patients presenting with cardiogenic shock
- •Patients with a known contraindication for primary PCI
- •Presentation ≥12 hours after symptom onset
结局指标
主要结局
Rate of "Target vessel failure" at 12 months of follow-up in association with IVUS measurements
时间窗: 2 years
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).
All-cause mortality at 12 months of follow-up in association with IVUS measurements
时间窗: 2 years
Co-primary study outcome will be the investigation of all-cause mortality (i.e., death from any cause) after hospitalization and during follow-up.
次要结局
- Post-PCI iFR measurement in association with IVUS measurements(2 years)
- Microtomographic thrombus volume in association with IVUS measurements(2 years)
- Pre-procedural angiographic outcomes in association with IVUS measurements(2 years)
- Νumber and type of stents in association with IVUS measurements(2 years)
- Radiation dose in association with IVUS measurements(2 years)
- Microtomographic thrombus porosity in association with IVUS measurements(2 years)
- Post-PCI stent underexpansion, deformation or malapposition in association with baseline IVUS measurements(2 years)
- In-hospital (post-PCI) adverse events in association with IVUS measurements(2 years)
- Post-procedural angiographic outcomes in association with IVUS measurements(2 years)
- Stent length and diameter in association with IVUS measurements(2 years)
- Procedural duration in association with IVUS measurements(2 years)
- Post-PCI edge dissection in association with baseline IVUS measurements(2 years)
- Post-PCI high plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts in association with baseline IVUS measurements(2 years)
- Microtomographic thrombus density in association with IVUS measurements(2 years)
- Contrast volume in association with IVUS measurements(2 years)
研究者
Karagiannidis Efstratios
Principal Investigator
Aristotle University Of Thessaloniki