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.
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
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Lou 新楼, 18601226301, xinlou301@sina.com
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.
- Conditions
- Cardiovascular Diseases
- 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.
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.
- First posted13 Aug 2026
- Study start7 Jan 2026
- Primary completion7 Jan 2029 (estimated)
- Study completion7 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Prognostic Value of Multiparametric Photon-Counting Cardiac CT in Patients With Prior Coronary Stent Implantation: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07763340
- Acronym / sponsor ID
- One-Stop Photon CT in Post-PCI
- Conditions
- Cardiovascular Diseases
- Keywords
- Radiology, Photon-Counting CT, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 7 Jan 2029 (estimated)
- Study completion
- 7 Jan 2029 (estimated)
- First posted
- 13 Aug 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 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiovascular diseases
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 13 Aug 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.
Xin Lou, Study Chair contact
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 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.