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Cardiovascular DiseasesNCT07763340

Photon-Counting Cardiac CT in Post-PCI Patients

An observational study of Cardiovascular Diseases, run by Chinese PLA General Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study takes patients who have undergone percutaneous coronary intervention as the research subjects and employs a prospective observational cohort design, aiming to develop and validate a "one-stop" photon-counting computed tomography imaging framework. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Cardiovascular Diseases
How many people
800 participants
Where
1 siteChina
Study dates
7 Jan 2026to 7 Jan 2029
How long will I take part?
3 Years
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with cardiovascular diseases

Who may be able to join

  • Age 18 years or older;
  • History of percutaneous coronary intervention with implantation of at least one coronary stent;
  • Ability to undergo iodinated contrast-enhanced CT;
  • Ability and willingness to provide written informed consent.

Who cannot join

  • Estimated glomerular filtration rate below the institutional threshold for contrast-enhanced CT, generally less than 30 mL/min/1.73 m², unless examination is clinically justified and approved according to institutional policy;
  • Known severe hypersensitivity to iodinated contrast material that cannot be adequately managed using the institutional premedication protocol; Pregnancy or suspected pregnancy;
  • Inability to provide informed consent or comply with study procedures;
  • Severe respiratory inability to perform the required breath-hold.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xin Lou, Study Chair contact

xinlou301@sina.com

China1 site, 1 recruiting
  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100039

    Lou 新楼, 18601226301, xinlou301@sina.com

    Recruiting

Other trials in China

About this study

Official title: Diagnostic Performance and Prognostic Value of Multiparametric Photon-Counting Cardiac CT in Patients With Prior Coronary Stent Implantation: A Prospective Cohort Study

This study takes patients who have undergone percutaneous coronary intervention as the research subjects and employs a prospective observational cohort design, aiming to develop and validate a "one-stop" photon-counting computed tomography imaging framework. The one-stop PCCT protocol implies that multiple assessments are acquired through a single examination, including coronary CT angiography for stent and native artery evaluation, resting first-pass myocardial iodine distribution imaging, and delayed myocardial extracellular volume quantification, with cardiac cine imaging performed in a prespecified dose-controlled substudy.

Read the detailed description

In the long-term management of patients after percutaneous coronary intervention, imaging assessment has become an indispensable tool for detecting in-stent restenosis, progression of native coronary artery disease, myocardial ischemia, and adverse ventricular remodeling. Current guidelines recommend various imaging modalities, including coronary CT angiography for stent and vessel evaluation, stress perfusion imaging for myocardial ischemia, and cardiac magnetic resonance for tissue characterization and ventricular function. However, traditional follow-up strategies require multiple separate examinations, which entail repeated contrast agent administration, cumulative radiation exposure, prolonged diagnostic timelines, and fragmented pathophysiological assessment. How to simultaneously evaluate coronary anatomy, myocardial iodine distribution, extracellular volume, and cardiac function through a single examination is a major clinical need that remains to be addressed.

This study takes patients who have undergone percutaneous coronary intervention as the research subjects and adopts a prospective observational cohort design. The aim is to innovatively develop and validate a "one-stop" photon-counting computed tomography imaging framework. The PCCT ONE-STEP protocol implies that multiple assessments are acquired through a single intravenous contrast injection and a single examination visit, including ultra-high-resolution coronary CT angiography for stent and native artery evaluation, spectral first-pass myocardial iodine distribution imaging, and low-dose delayed myocardial extracellular volume quantification. In a prespecified dose-controlled substudy, cardiac cine imaging and CT-derived strain analysis are additionally obtained.

The PCCT ONE-STEP protocol leverages the intrinsic spectral sensitivity and high spatial resolution of photon-counting detector technology. It can reduce the total volume of iodinated contrast medium and cumulative radiation dose compared with the sum of separate diagnostic examinations, while preserving or expanding the imaging content. By providing integrated coronary, myocardial iodine, extracellular volume, and functional phenotypes at a single visit, it has the potential to shorten the diagnostic work-up, decrease the incidence of contrast-associated adverse events, and improve patient throughput. The acquisition of multiple key imaging indicators enables individualized comprehensive assessment of post-PCI patients, supports the investigation of biological relevance through associations with circulating biomarkers, and facilitates the prediction of clinical ischemic and heart failure-related outcomes. The implementation of this study is expected to optimize the imaging pathway in the long-term care of patients after percutaneous coronary intervention.

Keywords
Radiology, Photon-Counting CT, Cardiovascular Diseases
Medical subject headings
Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Integrated Clinical Value of One-Stop Photon-Counting CT Phenotyping in Post-PCI Patients

    One-Stop photon-counting computed tomography examination in post-percutaneous coronary intervention patients performance, including coronary stent and native artery assessment, myocardial iodine distribution and extracellular volume quantification, functional strain imaging, diagnostic accuracy for angiographically significant in-stent restenosis (sensitivity, specificity, area under the curve), and prognostic association with major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, hospitalization for acute coronary syndrome, ischemia-driven revascularization,eg) over 12 months.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start7 Jan 2026
  3. Primary completion7 Jan 2029 (estimated)
  4. Study completion7 Jan 2029 (estimated)

Resources

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 only
Time perspective
Prospective
Enrolment
800 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07763340
Sponsor's protocol ID
One-Stop Photon CT in Post-PCI
Status last verified
Jan 2026
First submitted
10 Aug 2026
Last updated
13 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, 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 4 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: looking for participants now, as of the sponsor's last update on 13 Aug 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 Xiaomeng Fan (+8613203147909, fanxiaomeng@301hospital.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Integrated Clinical Value of One-Stop Photon-Counting CT Phenotyping in Post-PCI Patients (time frame: 3 years). 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 13 Aug 2026.

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Photon-Counting Cardiac CT in Post-PCI Patients | AzTrials