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

Not Applicable

Not yet recruiting

• Conditions: Angina, Stable; Coronary Artery Disease

• Registration Number: NCT05857904
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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).

Detailed 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 Timeline

• Study First Submitted: 2023-04-22
• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted QC: 2023-05-12
• Last Update Submitted: 2023-05-12
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-15
• Primary Completion: 2025-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4648

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1-year MACE	1-year	Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death; 2. myocardial infarction (MI); 3. Repeat myocardial revascularization; 4. non-lethal stroke

Secondary Outcome Measures

Name	Time	Method
non-lethal stroke	1-month, 6-month, 1-year, 2-years, 3-years	The American Heart Association/American Stroke Association (AHA/ASA) defines stroke as including the following types:CNS infarction,Ischemic stroke,Silent CNS infarction,Intracerebral hemorrhage,Subarachnoid hemorrhage,Cerebral venous thrombosis
The definite and probable stent thrombosis (defined by ARC-2 criteria)	1-month, 6-month, 1-year, 2-years, 3-years	The definite and probable stent thrombosis (defined by ARC-2 criteria) including acute, subacute, late, and very late stent thrombosis within a specific time frame.
All cause death	1-month, 6-month, 1-year, 2-years, 3-years	All cause death defined as: Cardiovascular death, non-cardiovascular death, death of unknown cause
repeat myocardial	1-month, 6-month, 1-year, 2-years, 3-years	Repeat myocardial defined as:Planned revascularization,Unplanned revascularization
Health Economics Evaluation Endpoints	1-month, 6-month, 1-year, 2-years, 3-years	Cost-effectiveness analysis, cost-utility analysis.; The information collected by the cost indicators is as follows: 1. Costs associated with initial hospitalization, including: 2. Estimated cost of major cardiovascular medication; 3. Total medical expenses related to major cardiac adverse events occurring during outpatient and/or hospitalization
Cumulative radiation exposure	1-month, 6-month, 1-year, 2-years, 3-years	Cumulative radiation exposure within1-month, 6-month, 1-year, 2-years and 3-years of study entry included all cardiovascular tests and invasive procedures, including CTA, myocardial perfusion imaging, and ICA.
Proportion of non-obstructive CAD detected by ICA examination	1-month, 6-month, 1-year, 2-years, 3-years	Proportion of non-obstructive CAD detected by ICA examination
MACE	1-month, 6-month, 2-years, 3-years	Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death; 2. myocardial infarction (MI); 3. Repeat myocardial revascularization; 4. non-lethal stroke
Non-fatal myocardial infarction (MI)	1-month, 6-month, 1-year, 2-years, 3-years	myocardial infarction (MI) defined as: Spontaneous myocardial infarction , perioperative myocardial infarction
Quality of life (QOL)	1-month, 6-month, 1-year, 2-years, 3-years	Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire. Angina status will be assessed using the Seattle Angina Questionnaire.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shagnhai, China