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Not yet recruiting NCT07620457

Spectral Precise Image Study for Coronary Artery

— Observational Cardiac

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study, Non-Interventional Study.
Who it may be relevant to
Registry conditions: Cardiac. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Non-Interventional Study
    This is an observational study
  • Device Non-Interventional Study
    This is an observational study

Primary outcome measures

  • 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.]
Secondary outcome measures (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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Zhengzhou Universtidy 1st Affiliated Hospital — Zhengzhou

Identifiers

NCT: NCT07620457 · 301167

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗