Clinical trial NCT03692936: Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment
Official title: Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment (CT-FFR-CHINA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Beijing heart century medical technology Co., Ltd
First posted: 2018-10-02
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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

Primary outcomes:
measure: sensitivity and specificity of CT-FFR compared with CCTA
timeFrame: 7days
Secondary outcomes:
measure: accuracy, positive predictive value, negative predictive value of CT-FFR compared with CCTA
timeFrame: 7days
measure: the area under the receiver operating characteristic curve of CT-FFR compared with CCTA
timeFrame: 7days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chao-Yang Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Jinan
country: China
facility: Qi Lu Hospital, Shan Dong University
state: Shandong
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhe Jiang University School of Medicine
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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.