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

NCT ID: NCT03692936

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 326 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-11-30

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing heart century medical technology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bin Lu

Professor and Director of the Department of Radiologic Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chao-Yang Hospital

Beijing, Beijing Municipality, China

Fuwai Hospital

Beijing, Beijing Municipality, China

Qi Lu Hospital, Shan Dong University

Jinan, Shandong, China

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

Hangzhou, Zhejiang, China

Countries

China

Facility Contacts

Tao Jiang, MD

Role: primary

Bin Lu, MD

Role: primary

Wenqiang Chen, MD

Role: primary

Hongjie Hu, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35391840 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34974364 (View on PubMed)

Other Identifiers

CNCCD

Identifier Type: -

Identifier Source: org_study_id