Coronary Artery DiseaseACCURATE-CTNCT04426396
Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT 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 blind evaluation, self-control, multicenter clinical trial designed to determine the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA), as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically significant coronary stenosis, using invasive… 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
- 339 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2020to 31 May 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: Subjects with stable angina or unstable angina who need selective surgery referred to coronary angiography and physiological evaluation.
Who may be able to join
- Age≥ 18 years old;
- Subjects with clinical need and consent for coronary angiography;
- Can provide the results of coronary CT angiography within 60 days prior to ICA or agree to undergo coronary CT angiography;
- The subjects knew about the experiment and signed the informed consent voluntarily.
Who cannot join
- Patients who have had percutaneous coronary intervention (PCI);
- Patients who had CABG;
- Acute coronary syndrome, such as acute ST segment elevation;
- Severe tachycardia or arrhythmia;
- Patients with severe hepatorenal insufficiency;
- Patients with congenital heart disease, implanted pacemaker or defibrillator, artificial heart valve;
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- Failure to perform invasive FFR examination or obtain FFR value due to various reasons;
- Allergic to β - blockers, nitrates and adenosine, sick sinus syndrome, long QT syndrome, severe hypotension, severe asthma, severe COPD or COPD;
- Persistent or significant clinical instability, including acute chest pain (sudden onset), cardiogenic shock, blood pressure instability (systolic blood pressure < 90mmHg) and severe congestive heart failure (according to the heart classification of the New York Heart Association, grade III or IV of cardiac function) or acute pulmonary edema;
- The CTA images of coronary artery showed that the stenosis rate was less than 30% or greater than 90%, or the diameter of diseased segment was less than 2.0mm;
- CT-FFR can not be calculated because of the quality of CTA image;
- Known pregnant and lactating women;
- Having participated in other clinical trials within 3 months;
- Other situations that the researchers judged were not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Coronary CT Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease
This is a blind evaluation, self-control, multicenter clinical trial designed to determine the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA), as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically significant coronary stenosis, using invasive fractional flow reserve (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 CT-FFR
FFR measured by pressure wire, CT-FFR computed by coronary CT angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of CT-FFR compared to FFR
Measured: 1 day
Secondary outcomes (1)
Diagnostic accuracy and AUC of CT-FFR compared to FFR
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Apr 2020
- Primary completion31 Dec 2021
- Study completion31 May 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
- 339 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426396
- Sponsor's protocol ID
- 2019-375
- Acronym
- ACCURATE-CT
- Status last verified
- May 2022
- First submitted
- 7 Jun 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li C, Hu Y, Jiang J, Dong L, Sun Y, Tang L, Du C, Yin D, Jiang W, Leng X, Jiang F, Pan Y, Jiang X, Zhou Z, Koo BK, Xiang J, Wang J; ACCURATE-CT Investigators. Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography: The ACCURATE-CT Study. JACC Cardiovasc Interv. 2024 Sep 9;17(17):1980-1992. doi: 10.1016/j.jcin.2024.06.027. Epub 2024 Aug 21.
PubMed 39177553
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
- Coronary CT Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04426396
- Acronym / sponsor ID
- ACCURATE-CT / 2019-375
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Hospital
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 11 Jun 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.
This is a blind evaluation, self-control, multicenter clinical trial designed to determine the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA), as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically significant coronary stenosis, using invasive fractional flow reserve (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
- Subjects with stable angina or unstable angina who need selective surgery referred to coronary angiography and physiological evaluation.
Key inclusion criteria (4 listed)
- Age≥ 18 years old;
- Subjects with clinical need and consent for coronary angiography;
- Can provide the results of coronary CT angiography within 60 days prior to ICA or agree to undergo coronary CT angiography;
- The subjects knew about the experiment and signed the informed consent voluntarily.
Key exclusion criteria (14 listed)
- Patients who have had percutaneous coronary intervention (PCI);
- Patients who had CABG;
- Acute coronary syndrome, such as acute ST segment elevation;
- Severe tachycardia or arrhythmia;
- Patients with severe hepatorenal insufficiency;
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: CT-FFRFFR measured by pressure wire, CT-FFR computed by coronary CT angiography | Diagnostic test | – |
Primary outcome
Sensitivity and specificity of CT-FFR compared to FFR
Time frame: 1 day
1 secondary outcome
Diagnostic accuracy and AUC of CT-FFR compared to FFR
Time frame: 1 day
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 39177553Li C, Hu Y, Jiang J, Dong L, Sun Y, Tang L, Du C, Yin D, Jiang W, Leng X, Jiang F, Pan Y, Jiang X, Zhou Z, Koo BK, Xiang J, Wang J; ACCURATE-CT Investigators. Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography: The ACCURATE-CT Study. JACC Cardiovasc Interv. 2024 Sep 9;17(17):1980-1992. doi: 10.1016/j.jcin.2024.06.027. Epub 2024 Aug 21.
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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 4 inclusion and 14 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?
Sensitivity and specificity of CT-FFR compared to FFR (time frame: 1 day). 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 NCT04426396, 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.