Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke

NCT ID: NCT02762552

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-14
• Study Completion Date: 2018-08-14

Brief Summary

In acute ischemic stroke, the identification of an etiology is of major importance to prevent recurrence by providing the best treatment. Because of numerous possible underlying etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic tests, which can be invasive, long and expensive. Moreover, many patients receive a diagnosis of undetermined stroke even after all available diagnosis tests are done, precluding optimal treatment.

Detailed Description

Asymptomatic MES detected by transcranial doppler have been reported in patient with ischemic stroke. It has been previously demonstrated that MES predict stroke recurrence and that the frequency of MES depends on stroke etiology. However, the pattern of MES has never been correlated to stroke etiology. Transcranial-holter is a novel ambulatory system which allows prolonged recording (up to 4 hours) leading to an increased detection of MES.

Therefore, transcranial holter with an 4 hour-recording will be performed for consecutive eligible patients hospitalized in our stroke care unit. During the recording, the patient will be able to continue their usual activities (eating, walking, speaking and sleeping).

All the included patients will have a classical follow-up at 3, 6 months and 12 months. The neurologist, blinded to the results of transcranial-holter, will have to prescribe and analyze the results of diagnostic tests to identify stroke etiology. Stroke etiology will be established according to the ASCOD classification. Questioning and neurological exam (NIHSS score) will be performed looking for potential recurrent stroke.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transcranial-holter monitoring

Transcranial doppler in patient with ischemic stroke

Group Type: EXPERIMENTAL

Transcranial-holter monitoring

Intervention Type: DEVICE

Transcranial holter with an 4 hour-recording

Interventions

Transcranial-holter monitoring

Transcranial holter with an 4 hour-recording

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ischemic stroke in the middle cerebral artery territory
• Acute ischemic stroke within the 7 first days from the onset of the symptoms
• Patient hospitalized in our stroke care unit
• Man or woman older than 18 years
• Patient affiliated to a social security system
• Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)

Exclusion Criteria

• Transient ischemic stroke
• Ischemic stroke in the vertebro-basilar or anterior cerebral artery territory.
• Proximal middle cerebral artery occlusion leading to the impossibility of recording
• Patient who could not express his consent
• Patient under guardianship or judicial protection
• Pregnant or breastfeeding woman
• Emergency situation
• Life expectancy under 6 months

• Absent of bilateral Acoustic window
• Analyzable Recording <30min

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pauline Renou

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2014/14

Identifier Type: -

Identifier Source: org_study_id