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NCT Number: NCT05780619

Diagnostic Performance of the Resistance Index (RI) for the Assessment of Cerebral Vasoreactivity in Transcranial Doppler

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Antonia Perez Martin

SUB_INVESTIGATOR

Isabelle AICHOUN

SUB_INVESTIGATOR

Salim ALLAL, MD

SUB_INVESTIGATOR

Sarah Coudray

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

    normal vasoreactivity defined as an increase in the mean of the maximum velocities > 30% measured by the cerebral vasoreactivity reference test

  2. 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

    normal vasoreactivity defined as an increase in the mean of the maximum velocities > 30% measured by the cerebral vasoreactivity reference test

  3. 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

    normal vasoreactivity defined as an increase in the mean of the maximum velocities > 30% measured by the cerebral vasoreactivity reference test

  4. 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

    normal vasoreactivity defined as an increase in the mean of the maximum velocities > 30% measured by the cerebral vasoreactivity reference test

  5. Correlation between delta resistance index and percentage response of vasoreactivity reference test

    Time frame: Day 1

    correlation coefficient

  6. Correlation between delta Gosling's pulsatility index and percentage response of vasoreactivity reference test correlation coefficient

    Time frame: Day 1

    correlation coefficient

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Coudray

CONTACT

[email protected]

04.66.6833.13

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: REVACEIR

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Mar 22, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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