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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with abnormal vasoreactivity |
| ||
| Patients with normal vasoreactivity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Doppler | Diagnostic Test | Measurement of resistance index on the middle cerebral artery (MCA) (index test) and the Holter (reference test). Patients will be randomized for order of tests |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 |
| 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 | Day 1 |
| 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 | Day 1 |
| 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 | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Coudray | Contact | 04.66.6833.13 | sarah.coudray@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Coudray | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes | Recruiting | Nîmes | France |
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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
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| 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 | Day 1 |
| 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 | Day 1 |
| 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 | Day 1 |
| Correlation between delta resistance index and percentage response of vasoreactivity reference test | correlation coefficient | Day 1 |
| Correlation between delta Gosling's pulsatility index and percentage response of vasoreactivity reference test correlation coefficient | correlation coefficient | Day 1 |
| Sensitivity of the difference in average Gosling's pulsatility index (delta) between the MCA on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity in symptomatic versus asymptomatic stenosis | Day 1 |
| Specificity of the difference in average Gosling's pulsatility index (delta) between the MCA on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity in symptomatic versus asymptomatic stenosis | Day 1 |
| Positive predictive value oof the difference in average Gosling's pulsatility index (delta) between the MCA on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity in symptomatic versus asymptomatic stenosis | Day 1 |
| Negative predictive value of the difference in average Gosling's pulsatility index (delta) between the MCA on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity in symptomatic versus asymptomatic stenosis | Day 1 |
| Sensitivity of the difference in average resistance index between the MCA on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity in symptomatic versus asymptomatic stenosis | Day 1 |
| Specificity of the difference in average resistance index between the MCA on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity in symptomatic versus asymptomatic stenosis | Day 1 |
| Positive predictive value of the difference in average resistance index between the MCA on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity in symptomatic versus asymptomatic stenosis | Day 1 |
| Negative predictive value of the difference in average resistance index between the MCA on the M1 segment contralateral and homolateral to the carotid lesion, to detect normal vasoreactivity in symptomatic versus asymptomatic stenosis | Day 1 |
| D014947 | Wounds and Injuries |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |