Photon-Counting Cardiac CT in Post-PCI Patients
ConditionCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Patients with cardiovascular diseases
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov