Actively Recruiting
Diagnostic Performance of the Resistance Index (RI) for the Assessment of Cerebral Vasoreactivity in Transcranial Doppler
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-04-03
77
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Routine revascularization of asymptomatic carotid stenosis is questionable as optimal medical therapy has significantly reduced the risk of stroke. Therefore, it is crucial to identify high-risk patients who may still benefit from carotid revascularization. In 2017, the ESC guidelines clarified the criteria associated with a high risk of stroke despite optimal treatment to consider a revascularization procedure, including altered cerebral vasoreactivity. However, cerebral vasoreactivity using transcranial Doppler ultrasound is reserved for qualified centers. It requires a technical platform and trained personnel, is time-consuming and generally not readily available. A simpler test is therefore necessary. The goal is to quickly and easily detect patients with normal vasoreactivity who do not benefit from the cerebral vasoreactivity test (reference standard) and to reserve the time-consuming cerebral vasoreactivity test for patients likely to have altered vasoreactivity. The hypothesis of the study is that on a routine measure in transcranial echo-Doppler, the resistance index (RI), can predict the response to the cerebral vasoreactivity test. With this new test, it will be possible to select patients who do not benefit from pharmacological cerebral vasoreactivity testing ("true negatives"). Thus, the time-consuming cerebral vasoreactivity test will be reserved only for patients with a possibility of impaired vasoreactivity.
CONDITIONS
Official Title
Diagnostic Performance of the Resistance Index (RI) for the Assessment of Cerebral Vasoreactivity in Transcranial Doppler
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has given free and informed consent and signed the consent form
- Patient is a member or beneficiary of a health insurance plan
- Carotid artery stenosis of 70% or more in diameter reduction (NASCET equivalent) or occlusion of atheromatous origin of the cervical internal carotid artery, symptomatic or asymptomatic
- Presence of a temporal window sufficient to record both homolateral and contralateral middle cerebral arteries
- Patient is of legal age and able to provide informed consent
- Patient has signed the consent form
- Patient is affiliated with or beneficiary of a health insurance plan
You will not qualify if you...
- Participation in another interventional study or within an exclusion period from a previous study
- Refusal to sign the consent form
- Inability to provide informed information
- Under legal protection such as safeguard of justice or guardianship
- Contraindication to Acetazolamide Diamox injection
- Absence of temporal acoustic window (no visualization of brain parenchyma or no recordable intracranial vessels)
- Insufficient temporal window (brain visible but no recordable middle cerebral artery)
- Internal or common carotid artery stenosis of 70% or more or occlusion on the side opposite to the primary lesion
- Stenosis of 50% or more in the middle cerebral artery either homolateral or contralateral to the cervical lesion
- Under court protection, guardianship, or conservatorship
- Dementia or disturbed consciousness preventing expression of will
- Inability to give informed information due to health reasons or language barrier
- Pregnant, parturient, or breastfeeding patient
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Nîmes
Nîmes, France
Actively Recruiting
Research Team
S
Sarah Coudray
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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