About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
Stenosis ≥ 70% in diameter reduction in NASCET equivalent or occlusion of atheromatous origin of the cervical internal carotid artery, asymptomatic or symptomatic.
Presence of a temporal window sufficient to record the homolateral and contralateral middle cerebral artery.
Disqualifiers
The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
Trial population
The study will be carried out at the University Hospital of Nîmes in the department of explorations and vascular medicine (EMV), for patients referred for HRV measurement with a significant stenosis or occlusion.
Trial design
Cohort
Prospective
Treatments tested in this trial
Transcranial Doppler
Diagnostic testMeasurement of resistance index on the middle cerebral artery (MCA) (index test) and the Holter (reference test). Patients will be randomized for order of tests
Treatment groups
Trial outcomes
Primary outcomes
Specificity of the difference in average resistance index (delta) between the middle cerebral artery (MCA) on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity
normal vasoreactivity defined as an increase in the mean of the maximum velocities \> 30% measured by the cerebral vasoreactivity reference test
Sensitivity of the difference in average resistance index (delta) between the middle cerebral artery (MCA) on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity
normal vasoreactivity defined as an increase in the mean of the maximum velocities \> 30% measured by the cerebral vasoreactivity reference test
Positive predictive value of the difference in average resistance index (delta) between the middle cerebral artery (MCA) on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity
normal vasoreactivity defined as an increase in the mean of the maximum velocities \> 30% measured by the cerebral vasoreactivity reference test
Negative predictive value of the difference in average resistance index (delta) between the middle cerebral artery (MCA) on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity
normal vasoreactivity defined as an increase in the mean of the maximum velocities \> 30% measured by the cerebral vasoreactivity reference test
Secondary outcomes
Sensitivity of the difference in average Gosling's pulsatility index (delta) between the middle cerebral artery (MCA) on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity
normal vasoreactivity defined as an increase in the mean of the maximum velocities \> 30% measured by the cerebral vasoreactivity reference test
Specificity of the difference in average Gosling's pulsatility index (delta) between the middle cerebral artery (MCA) on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity
normal vasoreactivity defined as an increase in the mean of the maximum velocities \> 30% measured by the cerebral vasoreactivity reference test
Positive predictive value of the difference in average Gosling's pulsatility index (delta) between the middle cerebral artery (MCA) on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity
normal vasoreactivity defined as an increase in the mean of the maximum velocities \> 30% measured by the cerebral vasoreactivity reference test
Negative predictive value of the difference in average Gosling's pulsatility index (delta) between the middle cerebral artery (MCA) on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity
normal vasoreactivity defined as an increase in the mean of the maximum velocities \> 30% measured by the cerebral vasoreactivity reference test
Sponsors and contacts
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