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Coronary Artery DiseaseCT-FFR-CHINANCT03692936

Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment

An observational study of Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Computed Tomography Derived Fractional Flow Reserve (CT-FFR) is a noninvasive method for evaluating the hemodynamic significance of coronary artery lesions by using coronary CT Angiography (CCTA) as opposed to invasive FFR examination under invasive coronary angiography. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
326 participants
Where
4 sitesChina
Study dates
1 Nov 2018to 30 Nov 2019
How long will I take part?
3 Months
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 coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis.

Who may be able to join

  • General Criteria:
  • Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI
  • Age > 18 years
  • Able to provide signed informed consent
  • CCTA inclusion criteria:
  • At least one stenosis with diameter stenosis of 30%-90% by visual estimate
  • Reference vessel size > 2 mm in stenotic segment by visual estimate

Who cannot join

  • General Criteria:
  • Ineligible for diagnostic intervention or FFR examination
  • Myocardial infarction within 72 hours
  • Severe heart failure (NYHA≥III)
  • S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
  • Allergy to contrast agent or adenosine
Show all 13Show fewer
  • Factors that might substantially impact the CCTA image quality, e.g, frequent atrial premature beat or atrial fibrillation
  • Angiographic exclusion criteria:
  • The interrogated stenosis is caused by myocardial bridge
  • Ostial lesions less than 3 mm to the aorta
  • Poor angiographic image quality precluding contour detection
  • Severe overlap of stenotic segments
  • Severe tortuosity of target vessel

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Chao-Yang Hospital

    Beijing, Beijing Municipality

    Tao Jiang, MD

  • Fuwai Hospital

    Beijing, Beijing Municipality

    Bin Lu, MD

  • Sir Run Run Shaw Hospital, Zhe Jiang University School of Medicine

    Hangzhou, Zhejiang

    Hongjie Hu, MD

  • Qi Lu Hospital, Shan Dong University

    Jinan, Shandong

    Wenqiang Chen, MD

Other trials in China

About this study

Official title: Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment (CT-FFR-CHINA)

Computed Tomography Derived Fractional Flow Reserve (CT-FFR) is a noninvasive method for evaluating the hemodynamic significance of coronary artery lesions by using coronary CT Angiography (CCTA) as opposed to invasive FFR examination under invasive coronary angiography. The purpose of the CT-FFR-CHINA study is to verify that the diagnostic performance of hemodynamically significant lesions by CT-FFR is superior than routine anatomic evaluation of diameter stenosis using CCTA alone using invasive FFR as the reference standard, exclusively in Chinese population.

Read the detailed description

Numerous studies have demonstrated high diagnostic accuracy of CCTA to detect and exclude coronary artery disease (CAD). One main limitation of CCTA, however, is a tendency to overestimate the severity of coronary artery stenosis against invasive coronary angiography (ICA). On the other hand, FFR, invasively measured under ICA, is recognized as the current gold standard in determination of coronary artery lesions due to improved long-term clinical outcomes when revascularization is guided by FFR instead of ICA. Moreover, prior studies indicated unreliable relationships between detection of obstructive anatomic coronary artery stenoses defined by CCTA and hemodynamically significant lesions by invasive fractional flow reserve (FFR).

Recent advances in artificial intelligence and computational modeling techniques now permit construction of a 3-dimensional model of coronary arteries visible from CCTA images and computation of FFR anywhere in the entire 3D model noninvasively. Several prior prospective, multicenter studies have reported promising results for the diagnostic performance of CT-FFR using invasive FFR as the reference standard. However, the diagnostic performance of CT-FFR in Chinese population is not clear. Therefore, we hereby designed the CT-FFR-CHINA study to determine the hemodynamically significant lesions, exclusively in Chinese subjects. It is a prospective and multi-center trial with a total of 326 subjects enrolled at 4 Chinese centers.

Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sensitivity and specificity of CT-FFR compared with CCTA

    In comparison to CCTA, sensitivity and specificity of CT-FFR determine whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard.

    Measured: 7days

Secondary outcomes (2)

  1. accuracy, positive predictive value, negative predictive value of CT-FFR compared with CCTA

    In comparison to CCTA, accuracy, positive predictive value, negative predictive value of CT-FFR to determine whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard

    Measured: 7days

  2. the area under the receiver operating characteristic curve of CT-FFR compared with CCTA

    In comparison to CCTA, the area under the receiver operating characteristic curve of CT-FFR in determining whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard

    Measured: 7days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study start1 Nov 2018 (estimated)
  3. Primary completion31 Aug 2019 (estimated)
  4. Study completion30 Nov 2019 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
326 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03692936
Sponsor's protocol ID
CNCCD
Acronym
CT-FFR-CHINA
Status last verified
Sep 2018
First submitted
30 Sep 2018
Last updated
2 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao N, An Y, Song L, Jiang T, Xu L, Hu H, Li L, Chen W, Li D, Zhang F, Fan L, Gao Y, Lu B. Diagnostic performance of CT-derived fractional flow reserve across coronary lesion morphologies: a prospective multicenter study. Int J Cardiovasc Imaging. 2026 Aug 31. doi: 10.1007/s10554-026-03807-5. Online ahead of print.

    PubMed 42671699

  • Gao Y, Zhao N, Song L, Hu H, Jiang T, Chen W, Zhang F, Dou K, Mu C, Yang W, Fu G, Xu L, Li D, Fan L, An Y, Wang Y, Li W, Xu B, Lu B. Diagnostic Performance of CT FFR With a New Parameter Optimized Computational Fluid Dynamics Algorithm From the CT-FFR-CHINA Trial: Characteristic Analysis of Gray Zone Lesions and Misdiagnosed Lesions. Front Cardiovasc Med. 2022 Mar 22;9:819460. doi: 10.3389/fcvm.2022.819460. eCollection 2022.

    PubMed 35391840

  • Gao Y, Zhao N, Song L, Hu F, Mu C, Gao L, Cui J, Yin D, Yang W, Xu B, Lu B. Diastolic versus systolic coronary computed tomography angiography derived fractional flow reserve for the identification of lesion-specific ischemia. Eur J Radiol. 2022 Feb;147:110098. doi: 10.1016/j.ejrad.2021.110098. Epub 2021 Dec 14.

    PubMed 34974364

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 4 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 7 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: status not confirmed, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

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 with CCTA (time frame: 7days). 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 NCT03692936, which also lists 3 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 2 Oct 2018.

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