Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stabl… (NCT05857904) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain
China4,648 participantsStarted 2023-05
Plain-language summary
This study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. Eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (CT-FFR guided group) or the control group (QFR guided group).
Who can participate
Age range18 Years
SexALL
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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 …