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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03985059
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Transcranial Doppler

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Nov 15, 2019
• Actual Primary Completion Date: Feb 15, 2021
• Actual Study Completion Date: Feb 15, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmique Adolphe de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT03985059
• Other Study ID Numbers: MMI_2018_12
• First Posted: Jun 13, 2019
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild: Verticalization; Doppler; Intracranial hemodynamic; Cerebral artery velocity
• Additional relevant MeSH terms: Cerebral Infarction; Infarction

Study Results

No Results Posted as of Mar 30, 2021