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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Bin Lu，Chinese Academy of Medical Sciences, Fuwai Hospital

Tracking Information

First Submitted Date ^ICMJE

September 30, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

August 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

sensitivity and specificity of CT-FFR compared with CCTA[ Time Frame: 7days ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

accuracy, positive predictive value, negative predictive value of CT-FFR compared with CCTA[ Time Frame: 7days ]
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
the area under the receiver operating characteristic curve of CT-FFR compared with CCTA[ Time Frame: 7days ]
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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational [Patient Registry]

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational [Patient Registry]
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

326

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 30, 2019

Estimated Primary Completion Date

August 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Bin Lu，Chinese Academy of Medical Sciences, Fuwai Hospital

Study Sponsor ^ICMJE

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Chinese Academy of Medical Sciences, Fuwai Hospital

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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