Coronary Artery DiseaseNCT07536607
Predictive Role of Photon Counting Computed Tomography in Acute Coronary Syndrom Patients
An observational study of Coronary Artery Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
For patients with severe calcification or complex non-calcified plaques, we investigate wether PCCT can enable non-invasive, in vivo precise differentiation and quantitative measurement of plaque components (e.g., spotty calcification, necrotic core, fibrous tissue). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 1 Dec 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: coronary artery disease patients referred to photon-counting CT examination
Who may be able to join
- Adult patients (≥18 years) with clinically diagnosed coronary artery disease or undergoing CCTA for chest pain/heart failure symptoms.
- Able and willing to provide informed consent and complete scheduled follow-up visits.
Who cannot join
- History of iodine contrast agent allergy.
- Severe renal insufficiency (eGFR < 30 mL/min/1.73 m²).
- History of prior coronary artery bypass grafting (CABG).
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Study ofPhoton Counting Computed Tomography in Acute Coronary Syndrom Patients
For patients with severe calcification or complex non-calcified plaques, we investigate wether PCCT can enable non-invasive, in vivo precise differentiation and quantitative measurement of plaque components (e.g., spotty calcification, necrotic core, fibrous tissue). Further we also study wether these quantitative imaging features can independently predict the risk of MACE in the short term and long term
Read the detailed description
Photon-counting detector CT (PCD-CT), as an innovative technology in the field of CT imaging, is gradually transforming the landscape of cardiac imaging. It differs significantly from conventional energy-integrating detector CT (EID-CT) in technical principles, bringing new possibilities for the diagnosis and assessment of heart diseases. This study will enrolled patients undergo standardized PCCT coronary angiography (CCTA) and make ultra-fine quantitative plaque analysis. Then at least 12 months of clinical follow-up will be performed. Finally correlation analysis between baseline plaque characteristics and follow-up endpoint events will be made.
- Conditions
- Coronary Artery Disease
- Being tested
- there is no intervention in this study
- Keywords
- photon-counting detector CT, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no intervention in this studyOther
there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease patients referred to photon-counting CT examination | coronary artery disease patients who underwent photon-counting CT will be enrolled, a sub-specialty trained cardiac radiologist and a sub-specialty trained cardiologist will analyze the image from the photon counting CT scans in detail. Receives: Other: there is no intervention in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events, MACE
Non-fatal myocardial infarction Non-fatal stroke Cardiovascular death Revascularization Acute heart failure
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Apr 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Ma, Chinese PLA General Hospital
- Investigators
- Jing ma, PhD,MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536607
- Sponsor's protocol ID
- M2026-004-01
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study ofPhoton Counting Computed Tomography in Acute Coronary Syndrom Patients
- ClinicalTrials.gov ID
- NCT07536607
- Acronym / sponsor ID
- M2026-004-01
- Conditions
- Coronary Artery Disease
- Keywords
- photon-counting detector CT, coronary artery disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 17 Apr 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.
For patients with severe calcification or complex non-calcified plaques, we investigate wether PCCT can enable non-invasive, in vivo precise differentiation and quantitative measurement of plaque components (e.g., spotty calcification, necrotic core, fibrous tissue). Further we also study wether these quantitative imaging features can independently predict the risk of MACE in the short term and long term
Detailed description
Photon-counting detector CT (PCD-CT), as an innovative technology in the field of CT imaging, is gradually transforming the landscape of cardiac imaging. It differs significantly from conventional energy-integrating detector CT (EID-CT) in technical principles, bringing new possibilities for the diagnosis and assessment of heart diseases. This study will enrolled patients undergo standardized PCCT coronary angiography (CCTA) and make ultra-fine quantitative plaque analysis. Then at least 12 months of clinical follow-up will be performed. Finally correlation analysis between baseline plaque characteristics and follow-up endpoint events will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease patients referred to photon-counting CT examination | – | Other: there is no intervention in this studycoronary artery disease patients who underwent photon-counting CT will be enrolled, a sub-specialty trained cardiac radiologist and a sub-specialty trained cardiologist will analyze the image from the photon counting CT scans in detail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- coronary artery disease patients referred to photon-counting CT examination
Key inclusion criteria (2 listed)
- Adult patients (≥18 years) with clinically diagnosed coronary artery disease or undergoing CCTA for chest pain/heart failure symptoms.
Key exclusion criteria (4 listed)
- History of iodine contrast agent allergy.
- Severe renal insufficiency (eGFR < 30 mL/min/1.73 m²).
- History of prior coronary artery bypass grafting (CABG).
- Pregnant or lactating women
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 |
|---|---|---|
| there is no intervention in this studythere is no intervention | Other | coronary artery disease patients referred to photon-counting CT examination |
Primary outcome
Major Adverse Cardiovascular Events, MACE
Time frame: 12months
Non-fatal myocardial infarction Non-fatal stroke Cardiovascular death Revascularization Acute heart failure
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 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Jing ma, PhD,MD principal investigator
Chinese PLA General Hospital
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 Coronary Artery Disease, run by Chinese PLA General Hospital 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 2 inclusion and 4 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 17 Apr 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 jing ma, PhD, MD, PhD,MD (+86 13681257396, crystalma@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events, MACE (time frame: 12months). 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 17 Apr 2026.