Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke

Stroke Clinical Trial

— VOICE  

Official title:

Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05547412
• Other study ID #: NA-01STR-03
• Secondary ID: U44NS109952
• Status: Terminated
• Start date: September 21, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2024
• Source: NovaSignal Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: January 31, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• NovaGuide 2 Intelligent Ultrasound System
The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows.

Locations

Country	Name	City	State
United States	CHI Memorial Hospital	Chattanooga	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
NovaSignal Corp.	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. Erratum In: Stroke. 2018 Mar;49(3):e139. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI When Compared Against Standard of Care Imaging.	The primary endpoint for both Phase 1 and Phase 2 of the study is to measure the AUC, Sensitivity, and Specificity of Velocity Curvature Index (VCI) when compared against standard of care CTA imaging for large vessel occlusion assessment. Initial assessment of outcome will be done after 18 months of study start and complete assessment will be done at the end of study's Phase 2.	1 day