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Head Pulse for Ischemic Stroke Detection (EPISODE)

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 29, 2019
First Posted Date January 31, 2019
Last Update Posted Date June 17, 2020
Actual Study Start Date August 1, 2017
Actual Primary Completion Date August 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2019)
Cranial accelerometry model [ Time Frame: Through study completion, likely 2 years ]
Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects
Original Primary Outcome Measures
 (submitted: January 29, 2019)
Cranial accelerometry model [ Time Frame: immediate ]
Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Head Pulse for Ischemic Stroke Detection
Official Title Measuring Cardiac Head Impulse to Detect Acute Large Vessel Ischemic Stroke
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acute Ischemic Stroke
Intervention Diagnostic Test: Cranial Accelerometry Measurement
Measuring the HeadPulse using cranial accelerometry
Study Groups/Cohorts Suspected acute stroke
Any patient with suspected acute stroke triggering a "stroke code" and had a brain imaging angiogram
Intervention: Diagnostic Test: Cranial Accelerometry Measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2020)
131
Original Estimated Enrollment
 (submitted: January 29, 2019)
60
Actual Study Completion Date August 18, 2019
Actual Primary Completion Date August 18, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03824496
Other Study ID Numbers 17-21846
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators Not Provided
PRS Account University of California, San Francisco
Verification Date June 2020