Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain - Clinical Trial for Angina, Stable | NCT05857904

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CT-FFR

QFR

About this trial

This is an interventional other trial for Angina, Stable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT-FFR guided group

QFR guided group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

1-year MACE

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

Secondary Outcome Measures

MACE

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

All cause death

All cause death defined as: Cardiovascular death, non-cardiovascular death, death of unknown cause

Non-fatal myocardial infarction (MI)

myocardial infarction (MI) defined as: Spontaneous myocardial infarction , perioperative myocardial infarction

repeat myocardial

Repeat myocardial defined as:Planned revascularization,Unplanned revascularization

non-lethal stroke

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)

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.

Proportion of non-obstructive CAD detected by ICA examination

Health Economics Evaluation Endpoints

Cost-effectiveness analysis, cost-utility analysis. The information collected by the cost indicators is as follows: Costs associated with initial hospitalization, including: Estimated cost of major cardiovascular medication Total medical expenses related to major cardiac adverse events occurring during outpatient and/or hospitalization

Quality of life (QOL)

Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire. Angina status will be assessed using the Seattle Angina Questionnaire.

Cumulative radiation exposure

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.

Full Information

NCT ID

NCT05857904

First Posted

April 22, 2023

Last Updated

May 12, 2023

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05857904

Brief Title

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

Acronym

CONFIDENT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2023 (Anticipated)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

May 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina, Stable, Coronary Artery Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

4648 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CT-FFR guided group

Arm Type

Experimental

Arm Description

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.

Arm Title

QFR guided group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

CT-FFR

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

QFR

Intervention Description

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.

Primary Outcome Measure Information:

Title

1-year MACE

Description

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

Time Frame

1-year

Secondary Outcome Measure Information:

Title

MACE

Description

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

Time Frame

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

Title

All cause death

Description

All cause death defined as: Cardiovascular death, non-cardiovascular death, death of unknown cause

Time Frame