Photon-Counting Cardiac CT in Post-PCI Patients

August 10, 2026 updated by: Xin Lou, Chinese PLA General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100039
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with cardiovascular diseases

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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;
  2. Known severe hypersensitivity to iodinated contrast material that cannot be adequately managed using the institutional premedication protocol; Pregnancy or suspected pregnancy;
  3. Inability to provide informed consent or comply with study procedures;
  4. Severe respiratory inability to perform the required breath-hold.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Integrated Clinical Value of One-Stop Photon-Counting CT Phenotyping in Post-PCI Patients
Time Frame: 3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • One-Stop Photon CT in Post-PCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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