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

Stroke Clinical Trial

— STAND  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03985059
• Other study ID #: MMI_2018_12
• Status: Terminated
• Start date: November 15, 2019
• Est. completion date: February 15, 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction
• Stroke

Intervention

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.

Locations

Country	Name	City	State
France	Fondation Ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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