Actively Recruiting

Age: 18Years +
All Genders
ID05780619

Diagnostic Performance of the Resistance Index (RI) for Assessing Cerebral Vasoreactivity Using Transcranial Doppler in Patients with Carotid Artery Stenosis or Occlusion

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-06-01

77

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a simpler way to assess cerebral vasoreactivity in patients with carotid artery stenosis or occlusion. While routine revascularization for asymptomatic carotid stenosis is uncertain due to reduced stroke risk from optimal medical therapy, identifying high-risk patients who may still benefit from revascularization is important. Current cerebral vasoreactivity testing using transcranial Doppler ultrasound is complex, requires specialized equipment and trained personnel, and is not widely available. This study evaluates the resistance index (RI), a routine measure from transcranial echo-Doppler, as a potential predictor of cerebral vasoreactivity. The goal is to use the RI to quickly identify patients with normal vasoreactivity who do not need the full pharmacological cerebral vasoreactivity test, which is time-consuming. Patients will undergo measurement of the RI on the middle cerebral artery, with randomization of test order between RI measurement and the reference vasoreactivity test. Participants will provide informed consent before enrollment and must meet specific criteria related to carotid artery stenosis or occlusion and temporal bone window suitability. Researchers will measure the difference in average resistance index between arteries on both sides of the brain on Day 1 and assess its accuracy in detecting normal vasoreactivity. Secondary measures include sensitivity and specificity of additional Doppler indices and their correlation with vasoreactivity. The study is observational and led by Centre Hospitalier Universitaire de Nîmes, with patient participation lasting a single study day.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
  • Patient has stenosis ≥ 70% diameter reduction or occlusion of atheromatous origin in the cervical internal carotid artery, symptomatic or asymptomatic
  • Presence of a temporal window sufficient to record the middle cerebral artery on both sides
  • Patient is of legal age (18 years or older)
Not Eligible

You will not qualify if you...

  • Participation in another interventional study or within exclusion period from a previous study
  • Refusal to sign the consent form
  • Unable to provide informed consent due to health reasons or language barrier
  • Under legal protection such as guardianship or conservatorship
  • Contraindication to Acetazolamide Diamox® injection
  • Absence or insufficiency of temporal acoustic window for ultrasound
  • Stenosis ≥ 70% or occlusion in the internal or common carotid artery contralateral to the primary lesion
  • Stenosis ≥ 50% in the middle cerebral artery on either side
  • Pregnant, breastfeeding, or giving birth at the time of the study
  • Patient with dementia, disturbed consciousness, or inability to express will properly due to health reasons or language barrier
  • Patient under court protection or similar legal status unable to consent properly
  • Patient in exclusion period from another study or refusing consent form signature
  • Patient unable to receive informed information due to health or language reasons
  • Patient pregnant, parturient, or breastfeeding during the study period
  • Patient refusing or unable to provide consent properly due to cognitive or legal reasons
  • Patient with insufficient temporal window for cerebral vessel recording
  • Patient with significant contralateral carotid or middle cerebral artery stenosis or occlusion

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo transcranial Doppler and Holter tests to assess cerebral vasoreactivity. The order of tests is randomized.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

CHU de Nîmes

Nîmes, France

Actively Recruiting

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Research Team

S

Sarah Coudray

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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