Coronary Artery DiseaseNCT04731285
Evaluation of Accuracy of CFD-based RuiXin-FFR by Comparing With Pressure-wire-based FFR
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Coronary Artery Disease (CAD) is the top killer nowadays. Pressure-wire-based Fractional Flow Reserve (FFR) is the gold standard for measuring ischemia in coronary arteries. CFD-based RuiXin-FFR, which is noninvasive, is developed recently. But its accuracy is not verified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Fractional Flow Reserve
- What is being tested?
- Pressure wire fractional flow reserve and CFD-based RuiXin-FFR
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2019to 31 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprised 330 stable patients with suspected or known CAD who underwent CCTA, and were referred to ICA, and FFR
Who may be able to join
- able to understand the purpose of the study and sign the informed consent
- with diagnosed or confirmed coronary artery disease according to the comprehensive clinical assessment
- with CTA image indicating that the diameter of the reference vessel in the stenosis segment was ≥2mm
- with CTA image indicating that the stenosis degree of coronary artery lumen diameter ≥30% and ≤90%
Who cannot join
- prior coronary artery bypass bypass (CABG) surgery, coronary interventional therapy (PCI), artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation
- persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure status (systolic pressure less than 90 mmHg), severe congestive heart failure (NYHA grade III or IV), or acute pulmonary edema
- acute myocardial infarction occurred within 7 days before inclusion
- complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and chronic renal damage (serum creatinine value > 1.5 mg/dl or creatinine clearance < 45 ml/Kg*1.73 m2)
- there are contraindications for the use of adenosine disodium triphosphate
- allergic to iodized contrast media
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- pregnancy or pregnancy status unknown
- life expectancy less than 2 months
- there are any factors that other researchers consider not suitable for inclusion or completion of this study
- obvious mismatch of coronary artery CTA images
- CTA image showing calcification occupies the cross-sectional area of the lumen > 80%
- CT value standard deviation of aortic root image >30HU
- coronary artery occlusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of RuiXin-FFR by Comparing With Pressure-wire-based FFR in Detecting Hemodynamically Significant Stenosis: A Prospective Multicenter Study
Coronary Artery Disease (CAD) is the top killer nowadays. Pressure-wire-based Fractional Flow Reserve (FFR) is the gold standard for measuring ischemia in coronary arteries. CFD-based RuiXin-FFR, which is noninvasive, is developed recently. But its accuracy is not verified. This is a multi-center and prospective study to evaluate the sensitivity, specificity, and accuracy of CFD-based RuiXin-FFR compared with wire-based FFR.
Read the detailed description
The participants are entered with suspended CAD and angiography ischemia between 30%-90% from 6 hospitals in China. Pressure-wire-based FFR is conducted in the standard protocol by each hospital. FFR>0.8 is chosen as the threshold to indicate non-ischemia. CFD-based RuiXin-FFR is performed by Raysight Medical (Shenzhen, China). CT images are acquired in a standard protocol by each hospital. Images with poor quality are excluded in this trial. Based on these images, RuiXin-FFR reconstructs the 3D model of coronary trees and obtains RuiXin-FFR values by conducting CFD simulations in a blinded fashion. RuiXin-FFR>0.8 is chosen as the threshold to indicate non-ischemia as well. By comparing the clinical diagnosis outcome of pressure-wire-based FFR and CFD-based RuiXin-FFR, the sensitivity and specificity of the RuiXin-FFR are obtained, which is the primary end point of this trial. The secondary end point includes the measurement of accuracy, NPV, PPV and ROC of the RuiXin-FFR.
- Being tested
- Pressure wire fractional flow reserve, CFD-based RuiXin-FFR
- Keywords
- Coronary Artery Disease, Myocardial Ischemia, FFR, FFRCT
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure wire fractional flow reserveDiagnostic test
Pressure wire is inserted into coronary arteries. The ratio of the average distal pressure and average aorta pressure is FFR.
CFD-based RuiXin-FFRDiagnostic test
CT-FFR was evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour
| Study group | Role | What they receive |
|---|---|---|
| Pressure wire based FFR | Pressure wire based FFR was reference group Receives: Diagnostic Test: Pressure wire fractional flow reserve | |
| CT-FFR | CFD-based RuiXin-FFR was test group Receives: Diagnostic Test: CFD-based RuiXin-FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
By comparing with pressure-wire-based FFR, the sensitivity and specificity of CFD-based RuiXin-FFR are measured
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start13 Mar 2019
- Primary completion14 May 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
- Investigators
- Zhanquan Li, MD, Principal investigator, Liaoning Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731285
- Sponsor's protocol ID
- 201901RX
- Status last verified
- Sep 2021
- First submitted
- 7 Oct 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng Y, Wang X, Tang Z, Li T, Jiang X, Ji F, Zhou Y, Ge J, Li Z, Zhao Y, Ma C, Mintz GS, Nie S. Diagnostic accuracy of CT-FFR with a new coarse-to-fine subpixel algorithm in detecting lesion-specific ischemia: a prospective multicenter study. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):129-137. doi: 10.1016/j.rec.2023.05.008. Epub 2023 Jul 13. English, Spanish.
PubMed 37453536
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of RuiXin-FFR by Comparing With Pressure-wire-based FFR in Detecting Hemodynamically Significant Stenosis: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04731285
- Acronym / sponsor ID
- 201901RX
- Keywords
- Coronary Artery Disease, Myocardial Ischemia, FFR, FFRCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 29 Jan 2021 (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 Artery Disease (CAD) is the top killer nowadays. Pressure-wire-based Fractional Flow Reserve (FFR) is the gold standard for measuring ischemia in coronary arteries. CFD-based RuiXin-FFR, which is noninvasive, is developed recently. But its accuracy is not verified. This is a multi-center and prospective study to evaluate the sensitivity, specificity, and accuracy of CFD-based RuiXin-FFR compared with wire-based FFR.
Detailed description
The participants are entered with suspended CAD and angiography ischemia between 30%-90% from 6 hospitals in China. Pressure-wire-based FFR is conducted in the standard protocol by each hospital. FFR>0.8 is chosen as the threshold to indicate non-ischemia. CFD-based RuiXin-FFR is performed by Raysight Medical (Shenzhen, China). CT images are acquired in a standard protocol by each hospital. Images with poor quality are excluded in this trial. Based on these images, RuiXin-FFR reconstructs the 3D model of coronary trees and obtains RuiXin-FFR values by conducting CFD simulations in a blinded fashion. RuiXin-FFR>0.8 is chosen as the threshold to indicate non-ischemia as well. By comparing the clinical diagnosis outcome of pressure-wire-based FFR and CFD-based RuiXin-FFR, the sensitivity and specificity of the RuiXin-FFR are obtained, which is the primary end point of this trial. The secondary end point includes the measurement of accuracy, NPV, PPV and ROC of the RuiXin-FFR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure wire based FFR | – | Diagnostic Test: Pressure wire fractional flow reservePressure wire based FFR was reference group |
| CT-FFR | – | Diagnostic Test: CFD-based RuiXin-FFRCFD-based RuiXin-FFR was test group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised 330 stable patients with suspected or known CAD who underwent CCTA, and were referred to ICA, and FFR
Key inclusion criteria (4 listed)
- able to understand the purpose of the study and sign the informed consent
- with diagnosed or confirmed coronary artery disease according to the comprehensive clinical assessment
- with CTA image indicating that the diameter of the reference vessel in the stenosis segment was ≥2mm
- with CTA image indicating that the stenosis degree of coronary artery lumen diameter ≥30% and ≤90%
Key exclusion criteria (13 listed)
- prior coronary artery bypass bypass (CABG) surgery, coronary interventional therapy (PCI), artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation
- persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure status (systolic pressure less than 90 mmHg), severe congestive heart failure (NYHA grade III or IV), or acute pulmonary edema
- acute myocardial infarction occurred within 7 days before inclusion
- complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and chronic renal damage (serum creatinine value > 1.5 mg/dl or creatinine clearance < 45 ml/Kg*1.73 m2)
- there are contraindications for the use of adenosine disodium triphosphate
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 |
|---|---|---|
| Pressure wire fractional flow reservePressure wire is inserted into coronary arteries. The ratio of the average distal pressure and average aorta pressure is FFR. | Diagnostic test | Pressure wire based FFR |
| CFD-based RuiXin-FFRCT-FFR was evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour | Diagnostic test | CT-FFR |
Primary outcome
Sensitivity and Specificity
Time frame: 9 days
By comparing with pressure-wire-based FFR, the sensitivity and specificity of CFD-based RuiXin-FFR are measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 37453536Zeng Y, Wang X, Tang Z, Li T, Jiang X, Ji F, Zhou Y, Ge J, Li Z, Zhao Y, Ma C, Mintz GS, Nie S. Diagnostic accuracy of CT-FFR with a new coarse-to-fine subpixel algorithm in detecting lesion-specific ischemia: a prospective multicenter study. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):129-137. doi: 10.1016/j.rec.2023.05.008. Epub 2023 Jul 13. English, Spanish.
- Individual participant dataSharing planned: No
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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.
Zhanquan Li, MD principal investigator
Liaoning Provincial People's Hospital
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 and Myocardial Ischemia, run by Beijing Anzhen 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 13 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: finished, as of the sponsor's last update on 5 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731285, which also lists 1 linked publication.
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 5 Sep 2021.