Coronary StenosisNCT04569669
The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis
A study testing FFR and FFRCT in people with Coronary Stenosis, run by CCRF Inc., Beijing, China at 8 sites in China.
Trial summary
The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- FFR and FFRCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 8 sitesChina
- Study dates
- 9 Oct 2020to 9 Mar 2022
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects that participate in this study must fulfill all the following criteria:
- General inclusion criteria:
- Age ≥18 years and ≤ 80 years;
- Subject providing written informed consent;
- After the researcher assessed the suspected presence of coronary artery stenosis, coronary angiography and CCTA examination were proposed.
- Angiographic inclusion criteria:
Show all 10Show fewer
- CCTA inspection should be performed on instruments with at least 64 multidetector rows;
- CCTA images are clear and readable;
- The diameter of coronary artery lesion stenosis was measured by CCTA image with 30%-90%;
- The reference vessel diameter of coronary stenosis was ≥2.5mm by CCTA imaging.
Who cannot join
- If subjects fulfill any of below criteria, this subject shall be exclude from this study.
- General exclusion criteria:
- Pregnant and breast-feeding women;
- Previous ST-segment elevation myocardial infarction 30 days before CCTA examination, and a history of non-ST-segment elevation myocardial infarction 7 days before CCTA examination;
- Prior Coronary Artery Bypass Graft（CABG）,Pacemaker, Implantable Cardioverter Defibrillator（ICD）, Artificial Valve Implantation;
- Hypertrophic obstructive cardiomyopathy;
Show all 24Show fewer
- Heart failure(NYHA≥III or Left Ventricular Ejection Fraction（LVEF）< 40%);
- Atrial fibrillation, supraventricular tachycardia, ventricular tachycardia and other arrhythmias;
- Body mass index >35kg/m2;
- Serum creatinine >178µmol/L or 2mg/dl;
- Allergies or contraindications to contrast agents are known;
- Subject who received Nicorandil within 2 weeks prior to invasive FFR examination;
- Any other conditions that are not suitable for the study.
- Angiographic exclusion criteria:
- The quality of CT imaging is not good enough to extract coronary blood vessel trees;
- Visual measurement of coronary lesion diameter stenosis > 90% by CCTA imaging;
- The target lesions were diffuse lesions, and the lesion length was ≥ 30mm (visual measurement);
- There were ≥ 2 stenosis lesions in the target vessel;
- Stent implantation in the target vessel;
- Lesions involving aneurysms or myocardial Bridges;
- The target vessel is very tortuous and it is difficult to predict the passage of the pressure guide wire.
- Left main disease;
- Patients with acute coronary syndrome after CCTA examination and before invasive FFR examination;
- Severe calcification(i.e Diffuse calcification ,Local or segmental calcification)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
The Second Hospital of Jilin University
Changchun, Jilin
Bin Liu, professor, +86-0431-88796739, liubin3333@vip.sina.com
The Second Hospital of Dalian University
Dalian, Liaoning
Peng Qu, professor, +86-0411-84671291 ext. 3098, qupeng777@aliyun.com
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jianhua Zhu, professor, +8613958039959, zjh-john2015@163.com
Nanjing First Hospital
Nanjing, Jiangsu
Shaoliang Chen, professor, +86-025-52271351, chmengx@126.com
General Hospital of Northern Theater Command
Shenyang, Liaoning
Yaling Han, professor, +86-024-28851120, hanyaling@263.net
Tianjin Chest Hospital
Tianjing, Tianjing
Hongliang Cong, professor, +86-022-88185003, hongliangcong@126.com
Wuhan Asia Heart Hospital
Wuhan, Hubei
Xi Su, professor, +86-027-65796888, yaxin_suxi@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Chunguang Qiu, professor, +8613803898806, qcg123@163.com
About this study
Official title: A Clinical Trial on the Diagnostic Performance Based on CT-Derived Fractional Flow Reserve Score Analysis Software for Coronary Artery Stenosis
The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.
Read the detailed description
The present study is a single arm, open label, prospective trial. Measurement of FFR during invasive cardiac catheterization represents the "gold standard" for assessment of the hemodynamic significance of coronary artery lesions. As we know, the major disadvantage of FFR is that it has to be measured invasively. CardioSimFFRct Analysis software is a non-invasive method to determine FFR which computes the hemodynamic significance of Coronary Artery Disease (FFRCT) from coronary computed tomography angiography（CCTA）data of the subject by using computational fluid dynamics.The FFR derived from FFR-CT will be compared with invasive FFR as gold standard.Moreover CardioSimFFRct also simplifies the coronary artery into a one-dimensional piping model, omits grid engineering, and greatly reduces the complexity of pretreatment.Based on the pressure loss along the pipe flow and the local pressure loss, a fast method for FFR calculation in engineering is proposed. The calculation time can be reduced to several minutes.
FFRct from CardioSimFFRct Analysis software is mainly based on CCTA images to image the coronary arteries. Through three-dimensional reconstruction of the coronary arteries and computational fluid Dynamics (CFD) technology, the simulation of blood flow in the blood vessels is realized to extract the coronary blood flow reserve score (FFR).FFRct has the following characteristics such as the FFR value can be measured noninvasively, without additional damage to patients, avoiding the risks brought by invasive surgery, and the side effects brought by drugs during invasive surgery.FFRct can realize the examination quickly, save the time of doctors' coronary functional assessment, and simplify the process of coronary functional assessment.It also has the function of three-dimensional reconstruction of blood vessels, which makes it convenient for users to view the whole structure of coronary arteries and make artificial correction.The results of FFRct have high repeatability and are easy for users to evaluate.
- Conditions
- Coronary Stenosis
- Being tested
- FFR and FFRCT
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR and FFRCTDiagnostic test
All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with Coronary Artery Disease（CAD）by CCTA | Experimental | Patients admitted to hospital with the diagnosed of CAD by CCTA and who accept to participate to the study will undergo the invasive coronary angiography, fractional flow reserve (FFR) will be measured during the invasive coronary angiography.Outcome measures were comparing FFRct to FFR. Receives: Diagnostic Test: FFR and FFRCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity (subject level) of FFRCT
Sensitivity and specificity (subject level) for predicting the functional significance of coronary artery stenosis using CT-Derived Fractional Flow Reserve Score Analysis Software.
Measured: Measurement at Procedure/Baseline Visit
Secondary outcomes (5)
AUC between FFRCT vs. FFR
Comparing the Area Under Curve(AUC) between FFRct and CCTA to determine the Functional significance of coronary stenosis.
Measured: Measurement at Procedure/Baseline Visit
Sensitivity and Specificity between FFRCT vs. FFR
Comparing the Sensitivity and Specificity which at the lesion level between FFRct and CCTA
Measured: Measurement at Procedure/Baseline Visit
Accuracy (lesion level and subject level) between FFRCT vs. FFR
Comparing the Accuracy which at the lesion level and subject level between FFRct and CCTA
Measured: Measurement at Procedure/Baseline Visit
Positive Predictive Value (PPV) between FFRCT vs. FFR
Comparing the positive predictive value (PPV) between FFRct and CCTA
Measured: Measurement at Procedure/Baseline Visit
Negative Predictive Value (NPV) between FFRCT vs. FFR
Comparing the negative predictive value (NPV) between FFRct and CCTA
Measured: Measurement at Procedure/Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start9 Oct 2020 (estimated)
- Primary completion9 Oct 2021 (estimated)
- Study completion9 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCRF Inc., Beijing, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shengshi Technology, Co., Ltd, Hangzhou, China
- Responsible party
- Sponsor
- Investigators
- Yaling Han, professor, Principal investigator, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569669
- Sponsor's protocol ID
- SS-YF-101-LCF01-Z
- Status last verified
- Sep 2020
- First submitted
- 30 Jul 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial on the Diagnostic Performance Based on CT-Derived Fractional Flow Reserve Score Analysis Software for Coronary Artery Stenosis
- ClinicalTrials.gov ID
- NCT04569669
- Acronym / sponsor ID
- SS-YF-101-LCF01-Z
- Conditions
- Coronary Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- CCRF Inc., Beijing, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Shengshi Technology, Co., Ltd, Hangzhou, China
- Study start
- 9 Oct 2020 (estimated)
- Primary completion
- 9 Oct 2021 (estimated)
- Study completion
- 9 Mar 2022 (estimated)
- First posted
- 30 Sep 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.
The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.
Detailed description
The present study is a single arm, open label, prospective trial. Measurement of FFR during invasive cardiac catheterization represents the "gold standard" for assessment of the hemodynamic significance of coronary artery lesions. As we know, the major disadvantage of FFR is that it has to be measured invasively. CardioSimFFRct Analysis software is a non-invasive method to determine FFR which computes the hemodynamic significance of Coronary Artery Disease (FFRCT) from coronary computed tomography angiography（CCTA）data of the subject by using computational fluid dynamics.The FFR derived from FFR-CT will be compared with invasive FFR as gold standard.Moreover CardioSimFFRct also simplifies the coronary artery into a one-dimensional piping model, omits grid engineering, and greatly reduces the complexity of pretreatment.Based on the pressure loss along the pipe flow and the local pressure loss, a fast method for FFR calculation in engineering is proposed. The calculation time can be reduced to several minutes.
FFRct from CardioSimFFRct Analysis software is mainly based on CCTA images to image the coronary arteries. Through three-dimensional reconstruction of the coronary arteries and computational fluid Dynamics (CFD) technology, the simulation of blood flow in the blood vessels is realized to extract the coronary blood flow reserve score (FFR).FFRct has the following characteristics such as the FFR value can be measured noninvasively, without additional damage to patients, avoiding the risks brought by invasive surgery, and the side effects brought by drugs during invasive surgery.FFRct can realize the examination quickly, save the time of doctors' coronary functional assessment, and simplify the process of coronary functional assessment.It also has the function of three-dimensional reconstruction of blood vessels, which makes it convenient for users to view the whole structure of coronary arteries and make artificial correction.The results of FFRct have high repeatability and are easy for users to evaluate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with Coronary Artery Disease（CAD）by CCTA | Experimental | Diagnostic Test: FFR and FFRCTPatients admitted to hospital with the diagnosed of CAD by CCTA and who accept to participate to the study will undergo the invasive coronary angiography, fractional flow reserve (FFR) will be measured during the invasive coronary angiography.Outcome measures were comparing FFRct to FFR. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and ≤ 80 years;
- Subject providing written informed consent;
- After the researcher assessed the suspected presence of coronary artery stenosis, coronary angiography and CCTA examination were proposed.
- CCTA inspection should be performed on instruments with at least 64 multidetector rows;
- CCTA images are clear and readable;
Key exclusion criteria (24 listed)
- If subjects fulfill any of below criteria, this subject shall be exclude from this study.
- Pregnant and breast-feeding women;
- Previous ST-segment elevation myocardial infarction 30 days before CCTA examination, and a history of non-ST-segment elevation myocardial infarction 7 days before CCTA examination;
- Prior Coronary Artery Bypass Graft（CABG）,Pacemaker, Implantable Cardioverter Defibrillator（ICD）, Artificial Valve Implantation;
- Hypertrophic obstructive cardiomyopathy;
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 |
|---|---|---|
| FFR and FFRCTAll the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization. | Diagnostic test | Patients diagnosed with Coronary Artery Disease（CAD）by CCTA |
Primary outcome
Sensitivity and specificity (subject level) of FFRCT
Time frame: Measurement at Procedure/Baseline Visit
Sensitivity and specificity (subject level) for predicting the functional significance of coronary artery stenosis using CT-Derived Fractional Flow Reserve Score Analysis Software.
5 secondary outcomes
AUC between FFRCT vs. FFR
Time frame: Measurement at Procedure/Baseline Visit
Sensitivity and Specificity between FFRCT vs. FFR
Time frame: Measurement at Procedure/Baseline Visit
Accuracy (lesion level and subject level) between FFRCT vs. FFR
Time frame: Measurement at Procedure/Baseline Visit
Positive Predictive Value (PPV) between FFRCT vs. FFR
Time frame: Measurement at Procedure/Baseline Visit
Negative Predictive Value (NPV) between FFRCT vs. FFR
Time frame: Measurement at Procedure/Baseline Visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Coronary Stenosis
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Yaling Han, professor principal investigator
The General Hospital of Northern Theater Command
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR and FFRCT in people with Coronary Stenosis, run by CCRF Inc., Beijing, China at 8 sites 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 10 inclusion and 24 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Yaling Han, professor (+86-024-28851120, hanyaling@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (subject level) of FFRCT (time frame: Measurement at Procedure/Baseline Visit). 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 Sep 2020.