Clinical trial NCT05547412: Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Official title: Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke
Acute Ischemic Stroke
Lead sponsor: NovaSignal Corp.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-09-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be enrolled from Stroke centers in the U.S.

Brief summary: This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s) and up to 40 non-evaluable subjects for the training phase.

Detailed description: The purpose of this study is to collect robust data from NovaGuide 2 Intelligent Ultrasound System to validate the Velocity Curvature Index (VCI) as a diagnostic biomarker tool to drive clinical decision making for assessing cerebral vascular occlusions confirmed by standard of care Computed Tomography Angiography (CTA) imaging.

Eligibility criteria: Inclusion Criteria:

1. Subject aged 18 years and older referred for evaluation of possible stroke.
2. Subject receives Computed Tomography Angiography (CTA) imaging for the assessment of stroke.
3. Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria:

1. Head CT findings consistent with acute primary intracranial hemorrhage (ICH), etc.
2. Subjects with occlusions in the distal or posterior circulation arteries.
3. Subjects who underwent partial or full craniotomy
4. Additional intracranial pathologies present (tumor, hydrocephalus, etc.)
5. Anticipated insufficient time to acquire a complete TCD scan as described by the protocol
6. Subjects who have a physical limitation preventing placement of the system.

Primary outcomes:
measure: Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI When Compared Against Standard of Care Imaging.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: CHI Memorial Hospital
state: Tennessee
Study officials:
affiliation: NovaSignal Corp.
name: Robert Hamilton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital Acute Stroke Severity Scale to Predict Large Artery Occlusion: Design and Comparison With Other Scales. Stroke. 2016 Jul;47(7):1772-6. doi: 10.1161/STROKEAHA.115.012482. Epub 2016 Jun 7.
citation: Smith EE, Kent DM, Bulsara KR, Leung LY, Lichtman JH, Reeves MJ, Towfighi A, Whiteley WN, Zahuranec DB; American Heart Association Stroke Council. Accuracy of Prediction Instruments for Diagnosing Large Vessel Occlusion in Individuals With Suspected Stroke: A Systematic Review for the 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke. Stroke. 2018 Mar;49(3):e111-e122. doi: 10.1161/STR.0000000000000160. Epub 2018 Jan 24.
citation: Thorpe SG, Thibeault CM, Wilk SJ, O'Brien M, Canac N, Ranjbaran M, Devlin C, Devlin T, Hamilton RB. Velocity Curvature Index: a Novel Diagnostic Biomarker for Large Vessel Occlusion. Transl Stroke Res. 2019 Oct;10(5):475-484. doi: 10.1007/s12975-018-0667-2. Epub 2018 Oct 6.
citation: Thorpe SG, Thibeault CM, Canac N, Wilk SJ, Devlin T, Hamilton RB. Decision Criteria for Large Vessel Occlusion Using Transcranial Doppler Waveform Morphology. Front Neurol. 2018 Oct 17;9:847. doi: 10.3389/fneur.2018.00847. eCollection 2018.
citation: Jalaleddini K, Canac N, Thorpe SG, O'Brien MJ, Ranjbaran M, Delay B, Dorn AY, Scalzo F, Thibeault CM, Wilk SJ, Hamilton RB. Objective Assessment of Beat Quality in Transcranial Doppler Measurement of Blood Flow Velocity in Cerebral Arteries. IEEE Trans Biomed Eng. 2020 Mar;67(3):883-892. doi: 10.1109/TBME.2019.2923146. Epub 2019 Jun 17.