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NCT Number: NCT07620457

Spectral Precise Image Study for Coronary Artery

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.

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Key information

Conditions

Cardiac

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional Study

Device

This is an observational study

Primary outcomes

  1. Subjective Image quality using 5 Liket-scale (1-5)

    Time frame: From date of image reconstruction until the date of image reading completion, anticipated 3Months.

    The subjective image quality will be assessed by 2 radiologists using Liket-scale on a range from 1(poor) to 5(Excellent).

Secondary outcomes

  1. Objective image quality

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

    The objective image quality will be evaluated by measuring the CT value shown in the image.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Liu

CONTACT

[email protected]

+863613852079

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Collaborators

  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

Image Quality Evaluation of Coronary CT Angiography Using Deep Learning-Based Spectral Precise Image Reconstruction

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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