StenosisREVACEIRNCT05780619
Diagnostic Performance of the Resistance Index (RI) for the Assessment of Cerebral Vasoreactivity in Transcranial Doppler
An observational study of Stenosis and Occlusion, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Transcranial Doppler
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2023to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- Patient of legal age with free and informed consent.
- Patient who has signed the consent form.
- Patient affiliated or beneficiary of a health insurance plan.
Who cannot join
- 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
- Contraindication to Acetazolamide Diamox® injection.
- Absence of temporal acoustic window (non visualization of the cerebral parenchyma, no recordable intracranial vessel).
Show all 15Show fewer
- Insufficient temporal window (visualizable brain parenchyma, no recordable MCA)
- Internal or common carotid artery stenosis ≥70% or occlusion, contralateral to the primary lesion.
- Stenosis ≥50% of the middle cerebral artery homolateral or contralateral to the cervical lesion.
- Patient in exclusion period determined by another study.
- Patient under court protection, guardianship, or conservatorship.
- Patient refusing to sign the consent form.
- Patient unable to express his or her will (dementia, disturbed consciousness, etc.)
- Patient for whom it is impossible to give informed information for health reasons or because of a language barrier.
- Pregnant, parturient, or breastfeeding patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Sarah Coudray
About this study
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.
- Being tested
- Transcranial Doppler
- Keywords
- Acetazolamide
- Medical subject headings
- Constriction, Pathologic, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial DopplerDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Patients with abnormal vasoreactivity | Not described Receives: Diagnostic Test: Transcranial Doppler | |
| Patients with normal vasoreactivity | Not described Receives: Diagnostic Test: Transcranial Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1
Secondary outcomes (14)
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
Measured: Day 1
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
Measured: 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
Measured: 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
Measured: Day 1
Correlation between delta resistance index and percentage response of vasoreactivity reference test
correlation coefficient
Measured: Day 1
Correlation between delta Gosling's pulsatility index and percentage response of vasoreactivity reference test correlation coefficient
correlation coefficient
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start9 Jun 2023
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Coudray, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780619
- Sponsor's protocol ID
- NIMAO/2022/SC-01
- Acronym
- REVACEIR
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of the Resistance Index (RI) for the Assessment of Cerebral Vasoreactivity in Transcranial Doppler
- ClinicalTrials.gov ID
- NCT05780619
- Acronym / sponsor ID
- REVACEIR / NIMAO/2022/SC-01
- Keywords
- Acetazolamide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with abnormal vasoreactivity | – | Diagnostic Test: Transcranial Doppler |
| Patients with normal vasoreactivity | – | Diagnostic Test: Transcranial Doppler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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.
- Patient of legal age with free and informed consent.
Key exclusion criteria (15 listed)
- 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
- Contraindication to Acetazolamide Diamox® injection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial DopplerMeasurement of resistance index on the middle cerebral artery (MCA) (index test) and the Holter (reference test). Patients will be randomized for order of tests | Diagnostic test | Patients with abnormal vasoreactivity, Patients with normal vasoreactivity |
Primary outcome
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
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
normal vasoreactivity defined as an increase in the mean of the maximum velocities > 30% measured by the cerebral vasoreactivity reference test
14 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
Time frame: Day 1
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
Time frame: 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
Time frame: 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
Time frame: Day 1
Correlation between delta resistance index and percentage response of vasoreactivity reference test
Time frame: Day 1
Correlation between delta Gosling's pulsatility index and percentage response of vasoreactivity reference test correlation coefficient
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Coudray principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stenosis and Occlusion, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Coudray (04.66.6833.13, sarah.coudray@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.