NCT05040958

Brief Summary

The aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck CTA images, and to determine whether this model is compatible with manual interpretations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

September 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

September 7, 2021

Last Update Submit

September 12, 2021

Conditions

Atherosclerosis of ArteryMetabolic SyndromeMachine Learning

Keywords

Atherosclerosis of ArteryMetabolic SyndromeMachine Learning

Outcome Measures

Primary Outcomes (1)

  • Correlation of the machine learning model and manual interpretation

    Evaluation of the correlation of the presence of plaque in the carotid segments with manual interpretation in the model obtained by machine learning method

    1 day

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People having cranial CTA

You may qualify if:

  • years or older
  • Having cranial CTA withdrawn
  • Having blood lipids, HbA1c, blood glucose, AST, ALT measured in 3 months before and 3 months after cranial CTA

You may not qualify if:

  • Thyroid disease
  • Having had neck surgery
  • Use of corticosteroids for more than 6 months
  • Presence of lymph nodes in the anterior neck
  • Hypertrophy of neck muscles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul MEdeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Kadıköy, Istanbul, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Elif Yıldırım Ayaz, M.D.

    Sultan Abdülhamid Han Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Yıldırım Ayaz, M.D.

CONTACT

+905325148300drelifyildirim@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 10, 2021

Study Start

September 8, 2021

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

TU(1)