Evaluation of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images

NCT04983927 | Completed

• 1 other identifier: HR-cASP-01
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

cASPECTS is a software that has been pre-learned based on ASPECTS Score of ischemic stroke patients using brain CT images, and clinical decision support system for scoring ASPECTS score by automatically analyzing brain CT images by assisting the medical team. The specific aims of this study are to evaluate efficacy of cASPECTS for scoring ASPECTS Score compared to the sensitivity and specificity levels of human expert.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Differences between ASPECTS scores in golden standard and in cASPECTS

  Mean difference between ASPECTS scores calculated by human experts and ASPECTS scores calculated by cASPECTS

  Within 4 weeks after collecting data

Study Arms (3)

Ischemic stroke positive

Patients diagnosed with acute ischemic stroke after a brain CT scan

Device: cASPECTS

Ischemic stroke negative with other brain disease

Patients who has not been diagnosed with acute ischemic stroke after a brain CT scan, but has been diagnosed with other brain diseases.

Device: cASPECTS

Ischemic stroke negative and no brain disease

Patients who has not been diagnosed with acute ischemic stroke after a brain CT scan and has not been diagnosed with other brain diseases.

Device: cASPECTS

Interventions

cASPECTS DEVICE

Clinical decision support system for scoring ASPECTS score

Ischemic stroke negative and no brain disease; Ischemic stroke negative with other brain disease; Ischemic stroke positive

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

(1) Adults over 19 years old (2) Brain CT acquired are confirmed to be enrolled

You may qualify if:

• Adults over 19 years old
• Brain CT acquired

You may not qualify if:

• Patients with ischemic stroke in posterior circulation
• Poor or incomplete brain CT image quality

Sponsors & Collaborators

• Heuron Inc.: lead

Study Sites (1)

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daehan Choi

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: July 30, 2021
• Study Start: August 11, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)