CardiacNCT07620457
Spectral Precise Image Study for Coronary Artery
An observational study of Cardiac, run by Philips Clinical & Medical Affairs Global at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac
- What is being tested?
- Non-Interventional Study
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients completed CCTA scan aged 18.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhengzhou Universtidy 1st Affiliated Hospital
Zhengzhou, Henan
Hua Wen Xue, 0371-66295624, zdyfygcp@163.com
About this study
Official title: Image Quality Evaluation of Coronary CT Angiography Using Deep Learning-Based Spectral Precise Image Reconstruction
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.
Read the 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.
- Conditions
- Cardiac
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyDevice
This is an observational study
Non-Interventional StudyDevice
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Group B | Scanning parameters 100kVp, DRI=24 Receives: Device: Non-Interventional Study | |
| Group A | Scanning parameters: 120kVp, DRI=30 Receives: Device: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From date of image reconstruction until the date of image reading completion, anticipated 3Months.
Secondary outcomes (1)
Objective image quality
The objective image quality will be evaluated by measuring the CT value shown in the image.
Measured: From the date of image reconstruction completion to the date of image reading completion, anticipated up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620457
- Sponsor's protocol ID
- 301167
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Sponsor and site need further discussion
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Quality Evaluation of Coronary CT Angiography Using Deep Learning-Based Spectral Precise Image Reconstruction
- ClinicalTrials.gov ID
- NCT07620457
- Acronym / sponsor ID
- 301167
- Conditions
- Cardiac
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | – | Device: Non-Interventional StudyScanning parameters 100kVp, DRI=24 |
| Group A | – | Device: Non-Interventional StudyScanning parameters: 120kVp, DRI=30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients completed CCTA scan aged 18.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyThis is an observational study | Device | Group B |
| Non-Interventional StudyThis is an observational study | Device | Group A |
Primary outcome
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).
1 secondary outcome
Objective image quality
Time frame: From the date of image reconstruction completion to the date of image reading completion, anticipated up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided. Sponsor and site need further discussion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac, run by Philips Clinical & Medical Affairs Global at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Liu (+863613852079, liujieict@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.