Spectral Precise Image Study for Coronary Artery

NCT07620457 | Not Yet Recruiting FDA Device

• 1 other identifier: 301167
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Objective image quality

  From the date of image reconstruction completion to the date of image reading completion, anticipated up to 3 months

Study Arms (2)

Group B

Scanning parameters 100kVp, DRI=24

Device: Non-Interventional Study

Group A

Scanning parameters: 120kVp, DRI=30

Device: Non-Interventional Study

Interventions

Non-Interventional Study DEVICE

This is an observational study

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients completed CCTA scan aged 18.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: collaborator
• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Zhengzhou Universtidy 1st Affiliated Hospital

Zhengzhou, Henan, China

Location

Central Study Contacts

Jie Liu

CONTACT

+863613852079; liujieict@163.com

Study Design

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

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

CN (1)