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

NCT05857904 | Not Yet Recruiting

• 1 other identifier: RX-RD-FFR-FA-001
• Study Type: interventional
• Target: 4,648
• Locations: 1 country
• Sites: 1

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).

Conditions

Angina, Stable; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 1-year MACE

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

  1-year

Secondary Outcomes (10)

• MACE

  1-month, 6-month, 2-years, 3-years

• All cause death

  1-month, 6-month, 1-year, 2-years, 3-years

• Non-fatal myocardial infarction (MI)

  1-month, 6-month, 1-year, 2-years, 3-years

• repeat myocardial

  1-month, 6-month, 1-year, 2-years, 3-years

• non-lethal stroke

  1-month, 6-month, 1-year, 2-years, 3-years

Study Arms (2)

CT-FFR guided group

EXPERIMENTAL

Patients randomized to the experimental group (CT-FFR guided group) will undergo coronary artery three-dimensional reconstruction and CT-FFR calculation using the coronary CT angiography (CCTA) images and RuiXin-FFR software. The researchers will interpret and analyze the clinical outcomes based on CT-FFR results. If CT-FFR is \>0.8, the patient will be treated with medical therapy alone. If CT-FFR is ≤0.8, further examination with coronary angiography will be performed. During the angiography examination, the operator will determine the treatment strategy (PCI, CABG, or medical therapy alone) based on the anatomical features of the lesion and the CT-FFR results.

Device: CT-FFR

QFR guided group

ACTIVE COMPARATOR

Patients randomized to the control group (QFR-guided group) will undergo invasive coronary angiography (ICA) in the catheterization lab, and QFR will be calculated using the ICA images. The researchers will interpret and analyze the clinical outcomes based on QFR results. If QFR is ≤0.8 and the lesion is suitable for intervention, the patient will undergo percutaneous coronary intervention (PCI) treatment. If QFR is \>0.8, the patient will be recommended for medical treatment alone.

Device: QFR

Interventions

CT-FFR DEVICE

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.

CT-FFR guided group

QFR DEVICE

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.

QFR guided group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shagnhai, 200032, China

Location

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• junbo Ge, doctor

  Fudan University

  STUDY CHAIR

Central Study Contacts

chenguang Li, doctor

CONTACT

13816767665; li.chenguang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 15, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)