CHU de Nîmes
Nîmes, France
Location status: Recruiting
Location contact
Anissa Megzari
CONTACT
Antonia Perez Martin
SUB_INVESTIGATOR
Isabelle AICHOUN
SUB_INVESTIGATOR
Salim ALLAL, MD
SUB_INVESTIGATOR
Sarah Coudray
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05780619
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nîmes, France
Location status: Recruiting
Anissa Megzari
CONTACT
Antonia Perez Martin
SUB_INVESTIGATOR
Isabelle AICHOUN
SUB_INVESTIGATOR
Salim ALLAL, MD
SUB_INVESTIGATOR
Sarah Coudray
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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
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
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
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
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
Time frame: Day 1
correlation coefficient
Time frame: Day 1
correlation coefficient
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nīmes
Other
Acronym: REVACEIR
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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