Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05857904
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* with stable chest pain who underwent CCTA and have at least 1 lesion with a percent diameter stenosis (DS%) between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment.These patients plan to undergo further non-invasive or invasive diagnosis and treatment.
* Able to undergo invasive coronary angiography (ICA)
* Capable of complying with the study procedures and fully understand the informed consent form approved by the ethics committee, and provide voluntary consent.
Exclusion Criteria:
General exclusion criteria:
* Patients with acute coronary syndrome requiring urgent revascularization.
* Patients with unstable angina, including those with first-onset chest pain within 48 hours, CCS III or higher first-onset angina, those whose angina has worsened to CCS III or IV within a short period of time, or those with rest angina lasting more than 20 minutes.
* Patients with iodine contrast agent allergy.
* Pregnant or lactating women.
* Patients with severe congestive heart failure (NYHA III-IV or LVEF \<30%) or acute pulmonary edema.
* Patients with severe renal insufficiency (creatinine \>150μmol/L or estimated - -glomerular filtration rate calculated by the Cockcroft-Gault formula \<45ml/kg/1.73 m2).
* Patients with other comorbidities and an expected survival time of less than 1 year.
* Patients who, for any other reason, are considered by the investigators to be unsuitable for inclusion in the study or unable to complete the study and follow-up.
Coronary CTA and coronary angiography exclusion criteria:
* Patients with a body mass index \>35 when undergoing coronary CT testing, resulting in poor CT image quality due to motion artifacts, severe calcification, or inadequate iodine contrast agent filling.
* Patients with a history of coronary artery bypass grafting (CABG).
* Target lesions related to acute myocardial infarction.
* Target lesions involving left main stem disease.
* Target lesions involving myocardial bridging.
* Target lesions involving in-stent restenosis.
* Low-quality angiography due to poor visualization of vascular boundaries or poor iodine contrast agent filling.
* Excessive overlap of the stenotic segment or severe tortuosity of the target vessel, making QFR calculation impossible.
Regen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05857904
Study Brief:
Protocol Section:
NCT05857904