Coronary Artery DiseaseNCT04493086
Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis
An observational study of Coronary Artery Disease, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Coronary CT angiography (CTA) or invasive coronary angiography (CAG) is usually performed to evaluate the severity of coronary stenosis depending on the probability of CAD. However, the stenosis severity is not closely corresponding with the hemodynamic significance in coronary arteries. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FFRCT-angio
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable coronary heart disease
Who may be able to join
- Patients with stable coronary heart disease undergoing CTA.
- Patients with at least one coronary artery stenosis of 50% - 90% in diameter ≥ 2mm.
- Within 30 days after CTA, CAG and FFR were determined by clinicians according to their condition.
Who cannot join
- Patients with myocardial infarction within 72 hours.
- Patients with coronary artery thrombosis.
- Patients with a history of allergy to contrast media or adenosine.
- NYHA class III-IV patients.
- Patients with previous CABG, target vessel PCI, pacemaker, ICD.
- Patients with a history of prosthetic valve implantation.
- Patients with myocardial bridges in the target vessels.
- Patients with severe arrhythmia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
Yue Li, PhD, 86-451-85552216, ly99ly@vip.163.com
About this study
Official title: Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis: a Prospective, Multicenter Clinical Study
Coronary CT angiography (CTA) or invasive coronary angiography (CAG) is usually performed to evaluate the severity of coronary stenosis depending on the probability of CAD. However, the stenosis severity is not closely corresponding with the hemodynamic significance in coronary arteries.
As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel. The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI should be considered if FFR≤0.80. However, FFR does have some limitations, such as risks of pressure wire injury, extra time and cost, and side effects of hyperemic agents.
To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is relatively low in lesions with severe calcification and/or tortuosity. Besides, the methodology of FFRCT relies on computational fluid dynamics, which is complicated and time consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis. The accuracy of QFR is also highly associated with anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem, thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior infarction-related or collateral donor arteries as well. Given the above issues concerning FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.
Read the detailed description
Cardiovascular disease remains the leading cause of death worldwide, and stable coronary artery disease (SCAD) accounts for the greatest proportion of cardiovascular disease. In the past decades, percutaneous coronary intervention (PCI) has become one of the most common treatments for SCAD, and therefore assessing the hemodynamic significance of coronary stenosis is important for physicians to make the optimal treating strategy. Coronary CT angiography (CTA) or invasive coronary angiography (CAG) is usually performed to evaluate the severity of coronary stenosis depending on the probability of CAD. However, the stenosis severity is not closely corresponding with the hemodynamic significance in coronary arteries.
As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel. The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI should be considered if FFR≤0.80. FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) study confirmed that FFR guided PCI was superior to angiography guided PCI in reducing major adverse cardiovascular events (MACE) in patients with multivessel disease. In the subsequent FAME 2 study, FFR guided PCI plus the optimal medical treatment (OMT), as compared with the OMT alone, decreased the composite event rates mainly driven by urgent revascularization in SCAD patients. However, FFR does have some limitations, such as risks of pressure wire injury, extra time and cost, and side effects of hyperemic agents.
To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is relatively low in lesions with severe calcification and/or tortuosity. Besides, the methodology of FFRCT relies on computational fluid dynamics, which is complicated and time consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis. The accuracy of QFR is also highly associated with anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem, thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior infarction-related or collateral donor arteries as well. Given the above issues concerning FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.
- Conditions
- Coronary Artery Disease
- Being tested
- FFRCT-angio
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFRCT-angioDiagnostic test
According to invasive coronary angiography (CAG) images, image databases of critical lesions, diffuse lesions, left main trunk lesions, ostium lesions and bifurcation lesions were established. In order to ensure that the position of the pressure guide wire sensor is consistent with that of FFRCT-angio, a professional with unknown FFR results is used to mark the position of the pressure wire sensor on the CAG image. The clinical information and characteristics of coronary artery lesions were collected, and the baseline data of patients were completed. The accuracy and diagnostic performance of FFRCT-angio in the diagnosis of functional stenosis (FFR < 0.8) were evaluated with FFR value measured by pressure guide wire as reference standard.
What is being measured
The primary outcome is the main question the study is designed to answer.
By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis
By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis
Measured: 5 days
Secondary outcomes (1)
By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis
By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493086
- Sponsor's protocol ID
- FFR
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis: a Prospective, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT04493086
- Acronym / sponsor ID
- FFR
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Jul 2020 (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.
Coronary CT angiography (CTA) or invasive coronary angiography (CAG) is usually performed to evaluate the severity of coronary stenosis depending on the probability of CAD. However, the stenosis severity is not closely corresponding with the hemodynamic significance in coronary arteries.
As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel. The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI should be considered if FFR≤0.80. However, FFR does have some limitations, such as risks of pressure wire injury, extra time and cost, and side effects of hyperemic agents.
To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is relatively low in lesions with severe calcification and/or tortuosity. Besides, the methodology of FFRCT relies on computational fluid dynamics, which is complicated and time consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis. The accuracy of QFR is also highly associated with anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem, thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior infarction-related or collateral donor arteries as well. Given the above issues concerning FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.
Detailed description
Cardiovascular disease remains the leading cause of death worldwide, and stable coronary artery disease (SCAD) accounts for the greatest proportion of cardiovascular disease. In the past decades, percutaneous coronary intervention (PCI) has become one of the most common treatments for SCAD, and therefore assessing the hemodynamic significance of coronary stenosis is important for physicians to make the optimal treating strategy. Coronary CT angiography (CTA) or invasive coronary angiography (CAG) is usually performed to evaluate the severity of coronary stenosis depending on the probability of CAD. However, the stenosis severity is not closely corresponding with the hemodynamic significance in coronary arteries.
As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel. The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI should be considered if FFR≤0.80. FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) study confirmed that FFR guided PCI was superior to angiography guided PCI in reducing major adverse cardiovascular events (MACE) in patients with multivessel disease. In the subsequent FAME 2 study, FFR guided PCI plus the optimal medical treatment (OMT), as compared with the OMT alone, decreased the composite event rates mainly driven by urgent revascularization in SCAD patients. However, FFR does have some limitations, such as risks of pressure wire injury, extra time and cost, and side effects of hyperemic agents.
To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is relatively low in lesions with severe calcification and/or tortuosity. Besides, the methodology of FFRCT relies on computational fluid dynamics, which is complicated and time consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis. The accuracy of QFR is also highly associated with anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem, thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior infarction-related or collateral donor arteries as well. Given the above issues concerning FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable coronary heart disease
Key inclusion criteria (3 listed)
- Patients with stable coronary heart disease undergoing CTA.
- Patients with at least one coronary artery stenosis of 50% - 90% in diameter ≥ 2mm.
- Within 30 days after CTA, CAG and FFR were determined by clinicians according to their condition.
Key exclusion criteria (8 listed)
- Patients with myocardial infarction within 72 hours.
- Patients with coronary artery thrombosis.
- Patients with a history of allergy to contrast media or adenosine.
- NYHA class III-IV patients.
- Patients with previous CABG, target vessel PCI, pacemaker, ICD.
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 |
|---|---|---|
| FFRCT-angioAccording to invasive coronary angiography (CAG) images, image databases of critical lesions, diffuse lesions, left main trunk lesions, ostium lesions and bifurcation lesions were established. In order to ensure that the position of the pressure guide wire sensor is consistent with that of FFRCT-angio, a professional with unknown FFR results is used to mark the position of the pressure wire sensor on the CAG image. The clinical information and characteristics of coronary artery lesions were collected, and the baseline data of patients were completed. The accuracy and diagnostic performance of FFRCT-angio in the diagnosis of functional stenosis (FFR < 0.8) were evaluated with FFR value measured by pressure guide wire as reference standard. | Diagnostic test | – |
Primary outcome
By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis
Time frame: 5 days
By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis
1 secondary outcome
By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by First Affiliated Hospital of Harbin Medical University 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Li, PhD (86-451-85552216, ly99ly@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis (time frame: 5 days). 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 30 Jul 2020.