STAND: iSchemic sTroke evAluated at Bed Side With ultrasouND

NCT04180826 | Terminated

• 1 other identifier: 2018-A03454-51
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stenosis

Patients with stenosis

Other: Observational

No stenosis

Patients without stenosis

Other: Observational

Interventions

Observational OTHER

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.

No stenosis; Stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with ischemic stroke or transient ischemic attack of less than 48 hours with or without carotid stenosis greater than 50% NASCET or occlusion

You may qualify if:

• 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
• \- Carotid stenosis of more than 50% NASCET or an occlusion
• Criteria for including witnesses - Absence of carotid stenosis greater than 50% NASCET or occlusion
• \- Disrupted vigilance

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Hopital Lariboisière: collaborator

Study Sites (1)

Mikaël Mazighi

Paris, France

Location

MeSH Terms

Conditions

Ischemic Stroke; Carotid Stenosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: January 15, 2019
• Primary Completion: January 15, 2021
• Study Completion: March 3, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)