Mapping the Natural History of Parenychymal and Cerebral Perfusion Changes in Acute Ischemic and Hemorrhagic Strokes

Acute Ischemic Stroke Clinical Trial

Official title:

Mapping the Natural History of Parenychymal and Cerebral Perfusion Changes in Acute Ischemic and Hemorrhagic Strokes Using Cranial Ultrasound and Continuous Trans-Cranial Doppler

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865795
• Other study ID #: IRB00048743
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Wake Forest University Health Sciences
• Contact: Sahil Kapoor
• Phone: (919) 987-6577
• Email: skapoor[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study using ultrasound of the brain as a diagnostic tool to differentiate between ischemic stroke and hemorrhagic stroke. Correlation of brain perfusion and size of stroke in relation to systemic hemodynamic targets will be assessed on serial scans.

Description:

To explore the correlation of brain parenchyma lesions changes and cerebral perfusion parameters as measured by cranial ultrasound transcranial Doppler to patient's blood pressure in a continuous fashion and correlate these to clinical and radiological features of cerebral perfusion. This study will lead to answering clinical management questions like is accurate diagnosis of hemorrhagic stroke possible that could be applied to the field evaluation of stroke patients, optimum blood pressure targets for different subsets of population studied ( multifocal disease, collateralized circulation etc), course of fluctuations in cerebral blood flow in response to systemic blood pressure changes or presence of persistent embolic signals in patients with presumed cardio-embolic strokes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients over the age of 18 who present to Wake Forest Baptist Hospital, get evaluated in the Emergency Department and /or admitted to inpatient/Intensive Care Unit and received any neuroimaging ordered by clinical team (head) (CT) (computerized tomography or Magnetic Resonance Imaging) (MRI) with diagnosis of acute ischemic or hemorrhagic strokes or stroke mimic or suspicion of intracranial pathology

Exclusion Criteria:

• Patients with Age < 18
• Incarcerate and Pregnant patients
• Penetrating cranial/head trauma or scalp wound

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Hemorrhagic Stroke
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of Images	The study will measure and record B mode images, any lesions seen and their size recorded and continuous Transcranial doppler (TCD) velocities acquired via Doppler. We would expect to explore the systemic hemodynamic correlates of cerebral blood flow parameters following acute ischemic and/or hemorrhagic strokes in relation to lesion size seen in B mode images. If patient receives concomitant CT or MRI per standard of care, comparisons to lesion size on CT/MRI will also be made.	Baseline
Primary	Measurement of Images	The images obtained through the study will be de-identified and shared with the Butterfly Team (ultrasound vendor) to work with the technical team under the contractual agreement to help create a cranial ultrasound preset that will increase the accuracy of ultrasound in Intracranial hemorrhage (ICH) detection.	Baseline