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NCT05857904

Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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).

Official title: Clinical Outcomes of CoroNary CTA-Derived FFR Versus ICA-Derived QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4648

Start Date

2023-05

Completion Date

2028-05

Last Updated

2023-05-15

Healthy Volunteers

Conditions

Angina, Stable Coronary Artery Disease

Interventions

DEVICE

CT-FFR

CT -FFR(coronary computed tomography angiography drived fractional flow reserve derived) uses routine coronary computed tomography angiography (CTA) images and applies a specific algorithm to extract both anatomical and physiological information of the coronary arteries. By combining these two pieces of information, a fluid dynamics model of the coronary arteries can be established, allowing the calculation of FFR at any location of the coronary arteries.

DEVICE

QFR

Quantitative flow ratio (QFR) is a new method for evaluating the functional significance of coronary artery stenosis based on angiography. It can be used for real-time detection of hemodynamic abnormalities in the coronary arteries in the catheterization lab. Unlike traditional methods that require the use of pressure wires and vasodilators such as adenosine, the QFR examination process only requires routine coronary angiography. By reconstructing the three-dimensional structure of the blood vessels and analyzing the hemodynamics, the QFR can evaluate the fractional flow reserve (FFR) without the need for pressure wires and vasodilators.

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

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shagnhai, China