Coronary StenosisCAREERNCT04665817
Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio (CAREER) Study
An observational study of Coronary Stenosis and Hemodynamics, run by Fudan University at 1 site in China.
Trial summary
To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Coronary Stenosis, Hemodynamics, Coronary Artery Disease
- What is being tested?
- CT-QFR, QFR and FFR
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Dec 2022
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrolled patients are adults with suspected CAD who underwent clinically indicated ICA after CT which indicates moderate coronary artery stenosis.
Who may be able to join
- Coronary CT angiography indicates that >= 1 stenosis with percent diameter stenosis between 30%-90% in a vessel >= 2mm.
- The invasive coronary angiography should be less than 30 days after the coronary CT angiography.
Who cannot join
- The target lesion has received coronary stent implantation or coronary artery bypass graft.
- Target lesion involves myocardial bridge.
- Severe heart failure (NYHA ≥III).
- Renal function is seriously damaged (eGFR<30 ml/min/1.73m2).
- Those who are contraindicated to use contrast agents, beta blockers, nitrates or adenosine drugs.
- Acute myocardial infarction within 1 month.
- The image quality of CTA or coronary angiography cannot be assessed.
- Any factors that affect the image quality of coronary CTA and coronary angiography, such as frequent premature contractions, atrial fibrillation, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinkai Qu
Shanghai, Shanghai Municipality, 200040
Xinkai Qu, MD,PhD, +86 13916320399, qxkchest@126.com
Tingwen Weng, MD, +86 13917769721, wengtingwen@alu.fudan.edu.cn
About this study
Official title: Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio Study
To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR.
Read the detailed description
This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.
- Conditions
- Coronary Stenosis, Hemodynamics, Coronary Artery Disease, Coronary Computed Tomography Angiography
- Being tested
- CT-QFR, QFR, FFR
- Keywords
- coronary stenosis, coronary computed tomography angiography, hemodynamics, CT-QFR, QFR
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-QFRDiagnostic test
Also called Fast Computational Approach to Derive Fractional Flow Reserve From Coronary CT Angiography
CT-QFR is a novel method for evaluating the functional significance of coronary stenosis. It is calculated by coronary computed tomographic angiography images.
QFRDiagnostic test
Also called Quantitative Flow Ratio
QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two. angiographic projections.
FFRDiagnostic test
Also called Fraction Flow Reserve
FFR measured by pressure wire is the gold standard for evaluating the functional significance of coronary stenosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of CT-QFR
Diagnostic accuracy of on-site CT-QFR in identifying physiologically significant coronary artery stenosis, using FFR as the reference standard.
Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.
Measured: 1.5 year
Secondary outcomes (4)
Comparision between CT-QFR and QFR
Use FFR as a reference standard to validate the non-inferiority of CT-QFR compared with QFR in the vessels without extensively calcified lesions defined by the combination of a cross-sectional calcium arc >90° and a thickness >1.5 mm. For CT-QFR, QFR and FFR evaluations, vessels with <=0.80 are regarded as having hemodynamically significant CAD.
Measured: 1.5 year
Other common measures of diagnostic performance of CT-QFR
Other common measures of diagnostic performance of CT-QFR, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) at the patient level compared with FFR as the reference standard.
Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.
Measured: 1.5 year
Correlation between CT-QFR and FFR
Pearson correlation or spearman's correlation will be used to quantify the correlations between CT-QFR and FFR. Agreements between CT-QFR and FFR will be assessed by Bland-Altman plot.
The correlation coefficient r=0-0.2 represents very weak or no correlation. 0.2-0.4 represents weak correlation. 0.4-0.6 represents moderate correlation. 0.6-0.8 represents strong correlation. 0.8-1.0 represents very strong correlation.
Measured: 1.5 year
The comparison between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%) and QCA-derived DS%
The comparison of the discrimination ability between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%), and QCA-derived DS% for identifying physiologically significant stenosis with FFR as the reference standard.
Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University -Pulse Medical Imaging Technology Joint Lab
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Xinkai Qu, MD,PhD, Principal investigator, Huadong Hospital, Department of CardiologyTingwen Weng, MD, Principal investigator, Huadong Hospital, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665817
- Sponsor's protocol ID
- Huadong Hospital
- Acronym
- CAREER
- Status last verified
- Jan 2022
- First submitted
- 7 Dec 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weng T, Ding D, Li G, Guan S, Han W, Gan Q, Li M, Qi L, Li C, Chen Y, Zhang L, Li T, Chang X, Chen Y, Wijns W, Qu X, Tu S. Accuracy of coronary computed tomography angiography-derived quantitative flow ratio for onsite assessment of coronary lesions. EuroIntervention. 2024 Oct 21;20(20):e1288-e1297. doi: 10.4244/EIJ-D-24-00336.
PubMed 39432253Weng T, Gan Q, Li Z, Guan S, Han W, Zhai X, Li M, Qi L, Li C, Chen Y, Zhang L, Chang X, Tu S, Qu X. Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol. BMJ Open. 2022 Jun 23;12(6):e055481. doi: 10.1136/bmjopen-2021-055481.
PubMed 35738652
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio Study
- ClinicalTrials.gov ID
- NCT04665817
- Acronym / sponsor ID
- CAREER / Huadong Hospital
- Conditions
- Coronary Stenosis, Hemodynamics, Coronary Artery Disease, Coronary Computed Tomography Angiography
- Keywords
- coronary stenosis, coronary computed tomography angiography, hemodynamics, CT-QFR, QFR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University -Pulse Medical Imaging Technology Joint Lab
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Dec 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.
To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR.
Detailed description
This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled patients are adults with suspected CAD who underwent clinically indicated ICA after CT which indicates moderate coronary artery stenosis.
Key inclusion criteria (2 listed)
- Coronary CT angiography indicates that >= 1 stenosis with percent diameter stenosis between 30%-90% in a vessel >= 2mm.
- The invasive coronary angiography should be less than 30 days after the coronary CT angiography.
Key exclusion criteria (8 listed)
- The target lesion has received coronary stent implantation or coronary artery bypass graft.
- Target lesion involves myocardial bridge.
- Severe heart failure (NYHA ≥III).
- Renal function is seriously damaged (eGFR<30 ml/min/1.73m2).
- Those who are contraindicated to use contrast agents, beta blockers, nitrates or adenosine drugs.
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-QFRAlso: Fast Computational Approach to Derive Fractional Flow Reserve From Coronary CT AngiographyCT-QFR is a novel method for evaluating the functional significance of coronary stenosis. It is calculated by coronary computed tomographic angiography images. | Diagnostic test | – |
| QFRAlso: Quantitative Flow RatioQFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two. angiographic projections. | Diagnostic test | – |
| FFRAlso: Fraction Flow ReserveFFR measured by pressure wire is the gold standard for evaluating the functional significance of coronary stenosis. | Diagnostic test | – |
Primary outcome
Diagnostic performance of CT-QFR
Time frame: 1.5 year
Diagnostic accuracy of on-site CT-QFR in identifying physiologically significant coronary artery stenosis, using FFR as the reference standard. Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.
4 secondary outcomes
Comparision between CT-QFR and QFR
Time frame: 1.5 year
Other common measures of diagnostic performance of CT-QFR
Time frame: 1.5 year
Correlation between CT-QFR and FFR
Time frame: 1.5 year
The comparison between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%) and QCA-derived DS%
Time frame: 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 39432253Weng T, Ding D, Li G, Guan S, Han W, Gan Q, Li M, Qi L, Li C, Chen Y, Zhang L, Li T, Chang X, Chen Y, Wijns W, Qu X, Tu S. Accuracy of coronary computed tomography angiography-derived quantitative flow ratio for onsite assessment of coronary lesions. EuroIntervention. 2024 Oct 21;20(20):e1288-e1297. doi: 10.4244/EIJ-D-24-00336.
- Derived from this study: PubMed 35738652Weng T, Gan Q, Li Z, Guan S, Han W, Zhai X, Li M, Qi L, Li C, Chen Y, Zhang L, Chang X, Tu S, Qu X. Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol. BMJ Open. 2022 Jun 23;12(6):e055481. doi: 10.1136/bmjopen-2021-055481.
- 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.
Xinkai Qu, MD,PhD principal investigator
Huadong Hospital, Department of Cardiology
Tingwen Weng, MD principal investigator
Huadong Hospital, Department of Cardiology
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 Stenosis and Hemodynamics, run by Fudan 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 2 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 25 Jan 2022. 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 Xinkai Qu, MD,PhD (+86 13916320399, qxkchest@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of CT-QFR (time frame: 1.5 year). 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 NCT04665817, which also lists 2 linked publications.
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 25 Jan 2022.