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

NCT05780619 | Recruiting

• 1 other identifier: NIMAO/2022/SC-01
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stenosis; Occlusion

Keywords

Acetazolamide

Outcome Measures

Primary Outcomes (4)

• 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

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

  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

  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

  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

  Day 1

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

  Day 1

Study Arms (2)

Patients with abnormal vasoreactivity

Diagnostic Test: Transcranial Doppler

Patients with normal vasoreactivity

Diagnostic Test: Transcranial Doppler

Interventions

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

Patients with abnormal vasoreactivity; Patients with normal vasoreactivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic; Bites and Stings

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Sarah Coudray

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Coudray

CONTACT

04.66.6833.13; sarah.coudray@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 22, 2023
• Study Start: June 9, 2023
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)