Carotid Atherosclerotic Plaque Load and Neck Circumference | NCT05040958

Studies
Carotid Atherosclerotic Plaque Load and Neck Circumference

NCT05040958

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Unknown status

Last Update Posted

Sep 17, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Atherosclerosis of Artery
Metabolic Syndrome
Machine Learning

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2021Actual

Primary Completion Date

Mar 28, 2022Estimated

Completion Date

Mar 28, 2022Estimated

First Submitted Date

Sep 7, 2021

First Submission Date that Met QC Criteria

Sep 7, 2021

First Posted Date

Sep 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2021

Last Update Posted Date

Sep 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elif Yıldırım Ayaz, Principal Investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyPrincipal Investigator

Lead Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Modeling CTA images for carotid artery segments with deep learning method and automatic carotid plaque presence and scoring will be useful and beneficial in clinical practice. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

People having cranial CTA

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elif Yıldırım Ayaz, M.D.	Contact	+905325148300		drelifyildirim@hotmail.com

Overall Officials

Name	Affiliation	Role
Elif Yıldırım Ayaz, M.D.	Sultan Abdülhamid Han Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul MEdeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital	Recruiting	Kadıköy	Istanbul	34668	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided