Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

This study is a multicenter, prospective, blinded, randomized controlled trial with event-driven non-inferiority design (blinding of clinical evaluators). A total of 4,648 participants will be recruited and randomly assigned to the CT-FFR guided group or the QFR guided group in a 1:1 ratio. Patients in the experimental group (CT-FFR guided group) will undergo three-dimensional reconstruction of coronary arteries and CT-FFR calculation using coronary CT angiography (CCTA) images and the RuiXin-FFR software. The CT-FFR results will be interpreted and analyzed by the researchers. If the CT-FFR value is >0.8, patients will receive medical therapy only, while if the CT-FFR value is ≤0.8, patients will undergo further coronary angiography to determine the appropriate treatment strategy (PCI, CABG, or medical therapy), based on the anatomical features of the lesion and CT-FFR results. Patients in the control group (QFR guided group) will undergo invasive coronary angiography (ICA) and QFR calculation based on ICA images. If the QFR value is ≤0.8 and the lesion is suitable for intervention, patients will receive PCI, while if the QFR value is >0.8, medical therapy will be recommended. Both groups will be followed up for clinical outcomes, health economics indicators, and quality of life at 1 month, 6 months, 1 year, 2 years, and 3 years. The occurrence of major adverse cardiovascular events (MACE) will be compared between the two groups. The study will also assess the effectiveness, safety, and economic value of CT-FFR in guiding diagnosis and treatment decisions for patients with stable angina, using QFR guided PCI as a control, with a non-inferiority comparison. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05857904
Study type	Interventional
Source	Shanghai Zhongshan Hospital
Contact	chenguang Li, doctor
Phone	13816767665
Email	li.chenguang@zs-hospital.sh.cn
Status	Not yet recruiting
Phase	N/A
Start date	May 2023
Completion date	May 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms