Photon-Counting Cardiac CT in Post-PCI Patients

NCT07763340 | Recruiting

• 1 other identifier: One-Stop Photon CT in Post-PCI
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases

Keywords

Radiology; Photon-Counting CT; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (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.

  3 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiovascular diseases

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Xiaomeng Fan

CONTACT

+8613203147909; fanxiaomeng@301hospital.com.cn

Xin Lou, Study Chair

CONTACT

xinlou301@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): January 7, 2029
• Study Completion (Estimated): January 7, 2029
• Last Updated: August 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)