Spectral Precise Image Study for Coronary Artery | NCT07620457

Studies
Spectral Precise Image Study for Coronary Artery

NCT07620457

Sponsor

Philips Clinical & Medical Affairs Global

Status

Not yet recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Cardiac

Interventions

Non-Interventional Study
Non-Interventional Study

Countries

China

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

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

May 11, 2026

First Submission Date that Met QC Criteria

May 27, 2026

First Posted Date

Jun 2, 2026Actual

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

May 27, 2026

Last Update Posted Date

Jun 2, 2026Actual

Name	Class
The First Affiliated Hospital of Zhengzhou University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single-center, comparative, observational, retrospective data study. Datasets from patients who underwent spectral coronary CT angiography (CCTA) for suspected coronary artery disease (CAD) or other diagnosis needs as part of their routine clinical evaluation will be included.

Detailed Description

Eligible dataset will be selected from the existing CT scan datasets generated at the study site, based on the CT scanning parameters, enrolled study participant datasets will be divided into Group A (120kVp, DRI=30) and Group B (100kVp, DRI=24). One hundred cases are planned to be enrolled in each group, with a total target of 200 datasets to be collected.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group B		Scanning parameters 100kVp, DRI=24	Device: Non-Interventional Study
Group A		Scanning parameters: 120kVp, DRI=30	Device: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Device	This is an observational study	Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective Image quality using 5 Liket-scale (1-5)	The subjective image quality will be assessed by 2 radiologists using Liket-scale on a range from 1(poor) to 5(Excellent).	From date of image reconstruction until the date of image reading completion, anticipated 3Months.

Secondary Outcomes

Measure	Description	Time Frame
Objective image quality	The objective image quality will be evaluated by measuring the CT value shown in the image.	From the date of image reconstruction completion to the date of image reading completion, anticipated up to 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Datasets from Patients who underwent spectral coronary CT angiography (CCTA).
Datasets from study participants with age ≥ 18 years old.
Scan parameters that meet the criteria defined in the 5.4.3.

Exclusion Criteria:

The clinical data information is considered incomplete after evaluation by the investigator.
The investigator determined that poor image quality (e.g. obvious artifacts, missing critical scan layers) would not satisfy post-processing analysis.
Data of patients deemed inappropriate for inclusion after evaluation by the investigator.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients completed CCTA scan aged 18.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jie Liu	Contact	+863613852079		liujieict@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhengzhou Universtidy 1st Affiliated Hospital		Zhengzhou	Henan		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Sponsor and site need further discussion

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided