Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT (PREDISP)

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    35
  • sponsor
    University Hospital, Montpellier
Updated on 2 May 2022

Summary

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.

Description

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).

Details
Condition Aneurysmal Subarachnoid Haemorrhage
Treatment Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake
Clinical Study IdentifierNCT04356599
SponsorUniversity Hospital, Montpellier
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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