- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05865795
Mapping the Natural History of Parenychymal and Cerebral Perfusion Changes in Acute Ischemic and Hemorrhagic Strokes
May 9, 2023 updated by: Wake Forest University Health Sciences
Mapping the Natural History of Parenychymal and Cerebral Perfusion Changes in Acute Ischemic and Hemorrhagic Strokes Using Cranial Ultrasound and Continuous Trans-Cranial Doppler
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sahil Kapoor
- Phone Number: (919) 987-6577
- Email: skapoor@wakehealth.edu
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Sahil Kapoor
- Phone Number: 919-987-6577
- Email: skapoor@wakehealth.edu
-
Principal Investigator:
- Aarti Sarwal, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aarti Sarwal, MD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
May 9, 2023
First Posted (Actual)
May 19, 2023
Study Record Updates
Last Update Posted (Actual)
May 19, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00048743
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification
IPD Sharing Time Frame
beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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