STAND: iSchemic sTroke evAluated at Bed Side With ultrasouND

Ischemic Stroke Clinical Trial

— STAND  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04180826
• Other study ID #: 2018-A03454-51
• Status: Terminated
• Start date: January 15, 2019
• Est. completion date: March 3, 2021

Study information

• Verified date: March 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: March 3, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
France	Mikaël Mazighi	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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