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

Terminated

• Conditions: Stroke
• Interventions: Other: Transcranial Doppler

• Registration Number: NCT03985059
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-13
• Study Start: 2019-11-15
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Transcranial Doppler	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.
Cases	Transcranial Doppler	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler	2 minutes	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).

Trial Locations

Locations (1)

Fondation Ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France