EPISODE: Head Pulse for Ischemic Stroke Detection

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT03824496
• Collaborator: (none)
• Enrollment: 131
• Location: 1
• Actual Duration (Months): 24.5
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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	Phase
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

• 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: Aug 1, 2017
• Actual Primary Completion Date: Aug 18, 2019
• Actual Study Completion Date: Aug 18, 2019

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Cranial accelerometry model [Through study completion, likely 2 years]

   Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UCSF	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03824496
• Other Study ID Numbers: 17-21846
• First Posted: Jan 31, 2019
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

No Results Posted as of Jun 17, 2020