Dual Energy CT for Confirming Hemorrhagic Transformation After Thrombectomy for Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- The presence or absence of intracerebral hemorrhage on DECT scans
研究概览
简要总结
The goal of this clinical trial is to investigate the use of DECT (Dual-Energy Computed Tomography) in patients with acute ischemic stroke who receive an intervention (thrombolysis or thrombectomy). The main questions to answer are:
- Can DECT more accurately differentiate hyperdensities as intracranial haemorrhage (ICH) or contrast extravasation compared with single-energy CT (SECT)?.
- Will DECT lead to better care for patients with AIS who receive intervention and have post-procedural hyperdensities?
Patients who receive intervention for acute ischemic stroke (AIS) receive a SECT at 24 hours as standard of care to determine if ICH is present. In the current study, a DECT will be done in addition to the SECT. Followup imaging (SECT or MRI) will be done at 72 hours to determine if the hyperdensity was indeed ICH. The accuracy of DECT for differentiating ICH from contrast extravasation will be compared.
详细描述
Background:
Stroke is a leading cause of death in the world and the majority of strokes are ischemic (80%). The first method of treating acute ischemic (AIS) is tissue plasminogen activator (tPA)[1, 2] , which is a thrombolytic medication that breaks up the blockage in the blood vessel. The second is called endovascular thrombectomy (EVT), which is a procedure where the clot is physically retrieved using a catheter[3]. While tPA can only be used within 4.5 hours, EVT can be used 16 hours[4] and even up to 24 hours[5] after a patient develops symptoms.
The go-to modality for imaging AIS is computed tomography (CT)[6, 7]. On a CT scan image, those objects that are brighter are hyperdense and those objects that are darker are hypodense. To determine the location of the blockage and complete the EVT procedure, contrast dye is used in combination with the CT. In patients presenting with delayed AIS, the CT-Perfusion (CTP) modality is also used, which can determine tissue that is receiving less blood flow but has not infarcted yet. Interestingly, CTP can also generate information about the permeability of the blood-brain barrier, which can be used to create a "permeability-surface area product map" (PS). Previous work by our group has demonstrated that using PS, the likelihood (not extent) of hemorrhagic transformation can be predicted[8].
Both tPA and EVT can lead to the complication of intracerebral hemorrhage (ICH). If ICH develops in a patient following AIS, the care-plan and prognosis is very different. Another complication, albeit less dangerous, is contrast extravasation (CE) into the region of the stroke. Contrast disappears after one to two days and does not affect the patient clinically. It is standard of care to perform a CT scan 24 hours after a patient receives AIS intervention to rule out ICH. Conventional, single-energy CT (SECT) uses one x-ray spectrum. Because contrast and blood are both significantly denser compared to surrounding tissue, they appear identical to one another. In dual-energy CT (DECT), two different x-ray spectra are used to create an additional "iodine overlay map" (IOM) and a "virtual-noncontrast" images [9-11]. By using the IOM and VNC images in conjunction with original SECT image, one can differentiate ICH from CE (Figure 1). DECT does not expose patients the higher levels of radiation compared to SECT and can be a useful technique for differentiating objects on CT.
We will perform a study looking at whether DECT can accurately identify hyperdensities caused from hemorrhage versus contrast. We will validate the role of DECT in post stroke care for those patients that undergo EVT and have post procedural hyperdensities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 greater than or equal to 18 years of age presenting with acute ischemic stroke (AIS) that are candidates for 1) thrombolysis (tPA) and/or 2) endovascular thrombectomy (EVT)
排除标准
- •Patients who are not candidates for tPA:
- •Intracerebral Hemorrhage on CT Ischemic Stroke within 3 months, Severe head trauma within 3 months Acute head trauma GI Malignancy or BI bleed within 21 days Coagulopathy (Platelets <100,000/mm3, INR >1.7, aPTT >40s, PT>15s) Anticoagulation (thrombin inhibitors, factor Xa inhibitors, low-molecular weight heparin) History of intracranial hemorrhage Intra-axial neoplasm Infective endocarditis Aortic Arch Dissection Patient receiving IV aspirin Patient receiving IV abciximab
- •Patients who are not candidates for EVT:
- •No large vessel occlusion on CT angiogram Baseline Modified Rankin Scale >3 No significant perfusion mismatch
研究组 & 干预措施
Dual Energy CT
Patients with acute stroke who receive intervention in the form of thrombolysis or EVT will receive dual-energy CT at the 24-hour mark in lieu of conventional single-energy CT.
干预措施: Dual Energy CT (Diagnostic Test)
结局指标
主要结局
The presence or absence of intracerebral hemorrhage on DECT scans
时间窗: 24 hours post intervention
The study population will first be separated into two categories: patients 1) with and 2) without hyperdensity seen on post-24 hour CT scan. DECT will be performed on both of these two groups. Of the patients with hyperdensity, we will further categorize them into two groups: 1) confirmed ICH and 2) confirmed CE or no hemorrhage. In DECT, three different images are obtained, one at high energy, one at low energy, and a mixed image. There are three parameters to separate ICH from CE on DECT: 1) if a hyperdensity is seen on the mixed-energy image and low-energy image but not the high-energy image it is ICH, 2) if a hyperdensity is seen on the mixed-energy image and the high-energy image but not the low-energy image, it is CE.
次要结局
- Length of Stay(Assessed up to 90 days)
- Level of Disability at 90 days post-stroke(90 days post date of first symptoms of acute stroke)
- Type of Intracerebral Hemorrhage (ICH)(Assessed up to 24 hours over which ICH is confirmed on imaging)
研究者
Jai Shankar
Professor
University of Manitoba