STAND: iSchemic sTroke evAluated at Bed Side With ultrasouND

NCT ID: NCT04180826

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-03-03

Brief Summary

Ischemic strokes account for more than 80% of strokes. Ischemic strokes are caused by the occlusion of an intracranial artery by a thrombus, responsible for tissue ischemia related to a decrease in local cerebral blood flow (CBS). Thus, the management of patients with Ischemic strokes is based on the preservation of an area that maintains sufficient intracranial hemodynamics (IH) and achieves the fastest possible recanalization. The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. In practice, variations in blood flow according to the positioning of the patient's body can be measured using a transcranial Doppler. It is a simple, non-invasive and painless examination that provides the patient's bed with data on the intracerebral hemodynamic profile of patients.

This study was implemented because there are no studies known to us that evaluate the effect of verticalization on intracerebral hemodynamics based on the presence of upstream arterial stenosis or occlusion and other multimodal evaluation data in transcranial Doppler.

Conditions

Ischemic Stroke; Carotid Stenosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Stenosis

Patients with stenosis

Observational

Intervention Type: OTHER

Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed, according to the usual care.

In a second step, the patient will be verticalized (from 0° to 90°). Intracranial hemodynamics parameters in supine position and during verticalization will be continuously recorded by attaching the ATYS TCD-X® transcranial Doppler helmet attached with glasses.

After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the ATYS TCD-X® helmet.

No stenosis

Patients without stenosis

Observational

Intervention Type: OTHER

Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed, according to the usual care.

In a second step, the patient will be verticalized (from 0° to 90°). Intracranial hemodynamics parameters in supine position and during verticalization will be continuously recorded by attaching the ATYS TCD-X® transcranial Doppler helmet attached with glasses.

After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the ATYS TCD-X® helmet.

Interventions

Observational

Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed, according to the usual care.

In a second step, the patient will be verticalized (from 0° to 90°). Intracranial hemodynamics parameters in supine position and during verticalization will be continuously recorded by attaching the ATYS TCD-X® transcranial Doppler helmet attached with glasses.

After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the ATYS TCD-X® helmet.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient over 18 years of age
• acute ischemic stroke or transient ischemic attack
• symptoms onset < 48 hours
• Absence of homolateral or downstream intracranial stenosis or M1 occlusion
• Verticalization authorized by the referent clinician.
• Rankin's score before AIC/AIT ≤ 2
• Non-opposition to participation in the study

Criteria for inclusion of cases

• Carotid stenosis of more than 50% NASCET or an occlusion

Criteria for including witnesses - Absence of carotid stenosis greater than 50% NASCET or occlusion

Criteria for non-inclusion

• Disrupted vigilance

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

Sponsors

Hopital Lariboisière

OTHER

Sponsor Role: collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mikaël Mazighi

Paris, , France

Countries

France

Other Identifiers

2018-A03454-51

Identifier Type: -

Identifier Source: org_study_id