STAND: iSchemic sTroke evAluated at Bed Side With ultrasouND (STAND)

Impact of Verticalization on Intracranial Hemodynamics Assessed by Continuous Transcranial Doppler Monitoring at the Acute Phase of Ischemic Stroke

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.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke; Carotid Stenosis
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Mikaël Mazighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with ischemic stroke or transient ischemic attack of less than 48 hours with or without carotid stenosis greater than 50% NASCET or occlusion

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stenosis; Patients with stenosis	Other: 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.
No stenosis; Patients without stenosis	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the monitoring of patient care	drop of more than 10% of the mean velocity between the supine and seated position	2 minutes after verticalization

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Collaborators: Hopital Lariboisière

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Brain Ischemia; Carotid Artery Diseases; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Carotid Stenosis; Cerebral Infarction
• Other Study ID Numbers: 2018-A03454-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No