Coronary Artery DiseaseACCURATENCT04814550
Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography
An observational study of Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FFR
- How many people
- 318 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2020to 24 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable angina, unstable angina or myocardial infarction after the acute phase
Who may be able to join
- Age ≥18 years;
- Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;
- Able to provide informed consent.
Who cannot join
- Subjects judged unsuitable for diagnostic intervention or FFR;
- Myocardial infarction within 6 days;
- LVEF ≤50%;
- eGFR <60ml/min（1.73m²）
- Severe coagulation dysfunction or bleeding disorders;
- Allergic to iodine contrast agent or adenosine, or ineligible for adenosine;
- Participated in other clinical trials within 1 months;
- Other situations that were not suitable for inclusion, as judged by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310009
About this study
Official title: Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease
This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.
- Conditions
- Coronary Artery Disease
- Being tested
- FFR
- 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.
FFRDiagnostic test
Also called AccuFFRangio
FFR measured by pressure wire, AccuFFRangio computed by coronary angiographic images
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
Hemodynamically significant coronary artery stenosis: FFR≤0.8
Measured: 7 days
Secondary outcomes (2)
Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
Hemodynamically significant coronary artery stenosis: FFR≤0.8
Measured: 7 days
AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis
Hemodynamically significant coronary artery stenosis: FFR≤0.8
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start4 Nov 2020
- Primary completion28 Jun 2021
- Study completion24 Feb 2022
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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 318 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814550
- Sponsor's protocol ID
- 2020-153
- Acronym
- ACCURATE
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang J, Hu Y, Li C, Dong L, Xu J, Tang L, Jiang W, Du C, Jiang X, Lyu Y, Leng X, Li C, Koo BK, Xiang J, Ge J, Wang J. Diagnostic Accuracy of Computational Fluid Dynamics-Based Fractional Flow Reserve Derived From Coronary Angiography: The ACCURATE Study. J Am Heart Assoc. 2025 Jan 7;14(1):e035672. doi: 10.1161/JAHA.124.035672. Epub 2024 Dec 24.
PubMed 39719423
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04814550
- Acronym / sponsor ID
- ACCURATE / 2020-153
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 24 Mar 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.
This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable angina, unstable angina or myocardial infarction after the acute phase
Key inclusion criteria (3 listed)
- Age ≥18 years;
- Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;
- Able to provide informed consent.
Key exclusion criteria (8 listed)
- Subjects judged unsuitable for diagnostic intervention or FFR;
- Myocardial infarction within 6 days;
- LVEF ≤50%;
- eGFR <60ml/min（1.73m²）
- Severe coagulation dysfunction or bleeding disorders;
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 |
|---|---|---|
| FFRAlso: AccuFFRangioFFR measured by pressure wire, AccuFFRangio computed by coronary angiographic images | Diagnostic test | – |
Primary outcome
Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
Time frame: 7 days
Hemodynamically significant coronary artery stenosis: FFR≤0.8
2 secondary outcomes
Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
Time frame: 7 days
AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis
Time frame: 7 days
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 8 Mar 2023.
- Derived from this study: PubMed 39719423Jiang J, Hu Y, Li C, Dong L, Xu J, Tang L, Jiang W, Du C, Jiang X, Lyu Y, Leng X, Li C, Koo BK, Xiang J, Ge J, Wang J. Diagnostic Accuracy of Computational Fluid Dynamics-Based Fractional Flow Reserve Derived From Coronary Angiography: The ACCURATE Study. J Am Heart Assoc. 2025 Jan 7;14(1):e035672. doi: 10.1161/JAHA.124.035672. Epub 2024 Dec 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Second Affiliated Hospital, Zhejiang University, School of Medicine 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: finished, as of the sponsor's last update on 8 Mar 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?
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?
Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard (time frame: 7 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 NCT04814550, 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 8 Mar 2023.