Prediction and Unraveling of Delayed Cerebral Ischemia in Patients With Subarachnoid Hemorrhage Using Early Dynamic 18F-FDG PET/CT Assessment of Cerebral Glucose Uptake (PREDISP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Quantification of Ki parameter.
研究概览
简要总结
A pilot trial for assessing early microvascular alterations after aneurysmal subarachnoid hemorrhage using dynamic 18F-FDG PET/CT. The primary endpoint will be the measure of early changes in cerebral glucose uptake reflecting microperfusion.
详细描述
We hypothesize that an early irreversible microvascular deterioration following initial bleeding could contribute to DCI occurrence. More precisely, we suspect that DCI areas are somehow overlaps of regions in which microperfusion is precociously altered, shortening circulatory reserves, and territories of secondarily spasmed arteries further lowering blood flow, resulting in ischemia. We aim to explore the potential microvasculature alteration through cerebral glucose perfusion and metabolism assessment using early dynamic 18F-fluorodesoxyglucose Positron Emission Tomography/Computer Tomography (dynamic 18F-FDG PET/CT). If our hypothesis turned out to be valid, we would at the same time be able to determine risk factors for this unpredictable complication and gain remarkable insight into DCI pathophysiology. Thus, the purpose of this trial is to demonstrate, in patients affected by SAH, the correlation between early cerebral glucose uptake defects in 18F-FDG PET/CT and delayed cerebral infarction in magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •written informed consent to participate in the study must be obtained from the subject or proxy/legal representative prior to enrollment.
- •males and females aged 18 years and older.
- •SAH proven by computed tomography (CT) and that has occurred within the last 72 hours.
- •ruptured saccular aneurysm angiographically confirmed by digital subtraction angiogram or CT angiogram, which has been successfully secured by surgical clipping or endovascular coiling.
- •high-risk subjects for DCI: "thick clot" on the hospital admission CT (grade 3 or grade 4 on the modified Fisher Scale).
- •a woman of childbearing potential is eligible only if the serum pregnancy test performed during the screening period is negative.
排除标准
- •PET/CT contradications
- •MRI contradications
- •gadolinium or meglumine hypersensitivity
- •glomerular filtration rate <30mL/min
- •SAH due to other causes than ruptured saccular aneurysm.
- •post-HSA cardiac arrest.
- •high sustained ICP ( >20mmHg lasting >20min) despite optimal treatment.
- •significant and concomitant organ failure amongst the following: hypotension with systolic blood pressure <90mmHg refractory to treatment; unresolved pulmonary edema or pneumonia with severe hypoxia defined as PaO2/FiO2 <150; severe cardiac failure requiring inotropic support.
- •patients with "do-not-resuscitate" orders, withdrawal of care situation, dying patient.
- •vulnerable patient populations (minor, legal vulnerability, prisoner)
- •pregnant and nursing mothers.
研究组 & 干预措施
Intervention Group
All participants will receive study intervention
干预措施: Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake (Other)
结局指标
主要结局
Quantification of Ki parameter.
时间窗: Day 2 +/- 1 day after the initial bleeding
A kinetic modeling for cerebral glucose uptake will be performed using in-house software in order to provide the Ki parameter (in min-1) in every voxel reflecting the cerebral metabolic rate of glucose in µmol/100g/min.
Quantification of K1 parameter.
时间窗: Day 2 +/- 1 day after the initial bleeding
A kinetic modeling for cerebral glucose uptake will be performed using in-house software in order to provide the K1 parameter (in min-1) in every voxel reflecting the cerebral blood flow (in mL/min).
次要结局
- Quantification of cerebral blood flow using DSC-MRI(At day 4 +/- 1 day after the initial bleeding)
- Delayed cerebral ischemic regions.(From day 2 to day 21 +/- 3 days after the initial bleeding)
- Quantification of cerebral blood flow using ASL-MRI(At day 4 +/- 1 day after the initial bleeding)
- Quantification of blood-brain-barrier permeability using DSC-MRI(At day 4 +/- 1 day after the initial bleeding)
- Quantification of blood-brain-barrier permeability using DCE-MRI(At day 4 +/- 1 day after the initial bleeding)
- Delayed spasmed arteries territories.(From day 2 to day 21 +/- 3 days after the initial bleeding)