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Head Pulse for Ischemic Stroke Detection (EPISODE)

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ClinicalTrials.gov Identifier: NCT03824496
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
Accurate diagnosis of stroke due to large vessel occlusion (LVO) is an essential step in providing acute stroke care to a community. The gold-standard for diagnosis LVO is brain imaging, which is impractical in the pre-hospital setting. A non-invasive method to detect LVO is needed. Using highly sensitive accelerometers, one can measure the "HeadPulse"- tiny forces exerted on the skull from the cardiac contraction. This study tests the hypothesis that LVO alters the HeadPulse characteristically. Analysis of these data along with the subjects vascular status (LVO vs. non-LVO as measured by CT angiography) will be used to create a model that can predict LVO status in suspect stroke subjects.

Condition or disease Intervention/treatment
Acute Ischemic Stroke Diagnostic Test: Cranial Accelerometry Measurement

Detailed Description:

Large vessel occlusion (LVO) ischemic stroke is a treatable disease at specialized centers. Clinical outcomes of patients with LVO is time-dependent. To maximize clinical benefit of thrombectomy, stroke systems of care need accurate methods to triage patients with LVO to comprehensive stroke centers or thrombectomy ready centers rather than closer primary stroke centers.

EPISODE will evaluate whether measurements of the HeadPulse can predict the presence or absence of LVO based on recordings from a consecutive series of patients undergoing CTA for suspected stroke. Recordings from patients pre- and post-thrombectomy will also be compared to investigate whether a systematic change in cranial forces exists during LVO.

Study Design
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Study Type : Observational
Actual Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Cardiac Head Impulse to Detect Acute Large Vessel Ischemic Stroke
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : August 18, 2019
Actual Study Completion Date : August 18, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
Suspected acute stroke
Any patient with suspected acute stroke triggering a "stroke code" and had a brain imaging angiogram
 Diagnostic Test: Cranial Accelerometry Measurement
Measuring the HeadPulse using cranial accelerometry


Outcome Measures
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Primary Outcome Measures :
  1. Cranial accelerometry model [ Time Frame: Through study completion, likely 2 years ]
    Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects


Eligibility Criteria
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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:   Non-Probability Sample
Study Population
Patients who have been evaluated by a medical professional who feels the subject may be experiencing an acute stroke and has triggered the acute stroke algorithm within the medical center.
Criteria

Inclusion Criteria:

  • Suspected acute stroke
  • CTA or MRA performed

Exclusion Criteria:

  • Any patient in whom obtaining a non-invasive recording is judged by the treating team to interfere with clinical assessment or treatment of the patient.
Contacts and Locations
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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): NCT03824496


Locations
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United States, California
UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03824496    
Other Study ID Numbers: 17-21846
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia