The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05865795
Recruitment Status : **RECRUITING NOW**
First Posted : May 19, 2023
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences
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Brief 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.
Acute Ischemic Stroke Hemorrhagic Stroke
Detailed 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.
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Study Type :
Observational
Estimated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
October 1, 2021
Estimated Primary Completion Date :
December 2024
Estimated Study Completion Date :
December 2024
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
Collection of Images [ Time Frame: Baseline ]
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.
Measurement of Images [ Time Frame: Baseline ]
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.
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Sampling Method:
Probability Sample
All adult patients presenting with stroke like presentation and suspicion of intracranial pathology will be screened on presentation to the Emergency Department and/or admission to WFBMC. Many pathologies look like strokes on presentation hence included as controls. Exclusion criteria will be age < 18, pregnant, incarcerated patients, or any scalp/cranial/ penetrating head trauma.
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
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05865795
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Contact: Sahil Kapoor 919-987-6577 skapoor@wakehealth.edu
Principal Investigator: Aarti Sarwal, MD
Wake Forest University Health Sciences
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Principal Investigator:
Aarti Sarwal, MD
Wake Forest University Health Sciences
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Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT05865795
Other Study ID Numbers:
IRB00048743
First Posted:
May 19, 2023 Key Record Dates
Last Update Posted:
May 19, 2023
Last Verified:
May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Yes
Plan Description:
Individual participant data that underlie the results reported in this article, after deidentification
Supporting Materials:
Study Protocol
Time Frame:
beginning 9 months and ending 36 months following article publication
Access Criteria:
Investigators whose proposed use of the data has been approved by an independent review committee
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences:
hypertensionhypotensionstroke therapycerebral perfusion
Additional relevant MeSH terms:
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Cardiovascular DiseasesStrokeIschemic StrokeHemorrhagic StrokeIschemiaCerebrovascular Disorders
Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesPathologic Processes
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
