NCT03692936

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

September 30, 2018

Last Update Submit

September 30, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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.

    7days

Secondary Outcomes (2)

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

    7days

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

    7days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis.

You may qualify if:

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

You may not qualify if:

  • 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
  • Factors that might substantially impact the CCTA image quality, e.g, frequent atrial premature beat or atrial fibrillation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chao-Yang Hospital

Beijing, Beijing Municipality, China

Location

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

Qi Lu Hospital, Shan Dong University

Jinan, Shandong, China

Location

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

Hangzhou, Zhejiang, China

Location

Related Publications (2)

  • 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.

    PMID: 35391840DERIVED

  • 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.

    PMID: 34974364DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director of the Department of Radiologic Imaging

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 2, 2018

Study Start

November 1, 2018

Primary Completion

August 31, 2019

Study Completion

November 30, 2019

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

CN(4)