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

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

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

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Aarti Sarwal, MD

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

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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