Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND)

Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND : iSchemic sTroke evAluated at Bed Side With ultrasouND)

The management of patients with ischemic stroke or transient ischemic attack is based on the preservation of a brain area by maintaining sufficient intracranial hemodynamics (IH) and with rapid 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. Variations in blood flow according to the positioning of the patient's body are measurable using a transcranial Doppler.

The main objective is to verify whether intracerebral hemodynamic changes during early verticalization after ischemic stroke or transient ischemic attack are more frequent in patients with carotid stenosis or occlusion compared to those without stenosis or occlusion.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Other: Transcranial Doppler

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation ophtalmique Adolphe de Rothschild

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

Participants will be recruited during their hospitalization in the USINV for the management of ischemic stroke.

Description

Inclusion Criteria:

• Ischemic stroke (AIC) or transient ischemic attack (AIT) of the carotid artery
• Duration of symptoms less than 48 hours
• Absence of homolateral or downstream intracranial stenosis or occlusion M1
• Lifting authorized by the referent clinician.

• Rankin's score before AIC/AIT ≤ 2

  • For cases:

• Carotid stenosis of more than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion

  • For controls:

• Absence of carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or occlusion

Exclusion Criteria:

- Disrupted vigilance

Secondary exclusion criteria:

• Absence of a homolateral temporal acoustic window at the lesion
• Impossibility to verticalize the patient

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients with ischemic stroke or transient ischemic attack who have carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion.	Other: Transcranial Doppler; Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed in the USINV, according to the usual care. In a second step, the patient will be verticalized (from 0° to 90°). HI parameters in supine position and during verticalization will be recorded continuously by placing the transcranial Doppler helmet. 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 helmet.
Controls; Patients with ischemic stroke or transient ischemic attack who do not have carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion.	Other: Transcranial Doppler; Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed in the USINV, according to the usual care. In a second step, the patient will be verticalized (from 0° to 90°). HI parameters in supine position and during verticalization will be recorded continuously by placing the transcranial Doppler helmet. 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 helmet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler	Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler (defined by a variation of more than 10%) on the symptomatic side evaluated in transcranial Doppler when changing from the lying position (0°) to the 90° position (measured 2 minutes after verticalization).	2 minutes

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Doppler; Verticalization; Intracranial hemodynamic; Cerebral artery velocity
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Cerebral Infarction
• Other Study ID Numbers: MMI_2018_12

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