Angina, StableCONFIDENTNCT05857904
Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain
A study testing CT-FFR and QFR in people with Angina, Stable and Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina, Stable, Coronary Artery Disease
- What is being tested?
- CT-FFR and QFR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,648 participants
- Where
- 1 siteChina
- Study dates
- May 2023to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Outcomes of CoroNary CTA-Derived FFR Versus ICA-Derived QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain
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).
Read the 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.
- Conditions
- Angina, Stable, Coronary Artery Disease
- Being tested
- CT-FFR, QFR
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FFRDevice
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.
QFRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: QFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year MACE
Major Adverse Coronary Event (MACE) rates, defined as:
- All cause death
- myocardial infarction (MI)
- Repeat myocardial revascularization
- non-lethal stroke
Measured: 1-year
Secondary outcomes (10)
MACE
Major Adverse Coronary Event (MACE) rates, defined as:
- All cause death
- myocardial infarction (MI)
- Repeat myocardial revascularization
- non-lethal stroke
Measured: 1-month, 6-month, 2-years, 3-years
All cause death
All cause death defined as:
Cardiovascular death, non-cardiovascular death, death of unknown cause
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
Non-fatal myocardial infarction (MI)
myocardial infarction (MI) defined as: Spontaneous myocardial infarction , perioperative myocardial infarction
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
repeat myocardial
Repeat myocardial defined as:Planned revascularization,Unplanned revascularization
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
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
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
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.
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
Proportion of non-obstructive CAD detected by ICA examination
Proportion of non-obstructive CAD detected by ICA examination
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
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
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
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.
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
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.
Measured: 1-month, 6-month, 1-year, 2-years, 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- junbo Ge, doctor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857904
- Sponsor's protocol ID
- RX-RD-FFR-FA-001
- Acronym
- CONFIDENT
- Status last verified
- May 2023
- First submitted
- 22 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of CoroNary CTA-Derived FFR Versus ICA-Derived QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain
- ClinicalTrials.gov ID
- NCT05857904
- Acronym / sponsor ID
- CONFIDENT / RX-RD-FFR-FA-001
- Conditions
- Angina, Stable, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,648 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-FFR guided group | Experimental | Device: CT-FFRPatients 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. |
| QFR guided group | Active comparator | Device: QFRPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-FFRCT -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 | CT-FFR guided group |
| QFRQuantitative 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. | Device | QFR guided group |
Primary outcome
1-year MACE
Time frame: 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
10 secondary outcomes
MACE
Time frame: 1-month, 6-month, 2-years, 3-years
All cause death
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
Non-fatal myocardial infarction (MI)
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
repeat myocardial
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
non-lethal stroke
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
The definite and probable stent thrombosis (defined by ARC-2 criteria)
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
Proportion of non-obstructive CAD detected by ICA examination
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
Health Economics Evaluation Endpoints
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
Quality of life (QOL)
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
Cumulative radiation exposure
Time frame: 1-month, 6-month, 1-year, 2-years, 3-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
Related trials for Angina, Stable
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
junbo Ge, doctor study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-FFR and QFR in people with Angina, Stable and Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chenguang Li, doctor (13816767665, li.chenguang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year MACE (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.