Clinical trial NCT01747317: Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography
Official title: Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: FFR
fractional flow reserve
CT
Computed Tomography
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

Detailed description: Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

Available data from registered clinical trials has testified the diagnostic performance of FFRCT, but the diagnostic accuracy among them are not consistent.

Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the diagnostic accuracy of FFRCT and find the possible cause for inconsistency

Eligibility criteria: Inclusion Criteria:

* Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter
* Undergoing clinically indicated invasive coronary angiography with FFR

Exclusion Criteria:

* A history of CABG surgery
* Prior percutaneous coronary intervention with suspected instent restenosis
* Suspicion of or recent acute coronary syndrome
* Complex congenital heart disease
* Prior pacemaker or defibrillator
* Prosthetic heart valve
* Significant arrhythmia
* heart rate \>100 beats/min
* systolic blood pressure≤90 mmHg
* contraindication to beta blockers, nitroglycerin or adenosine
* Serum creatinine level greater than 1.5 mg per dL
* Allergy to iodinated contrast
* Pregnant state
* Body mass index greater than 35
* Evidence of active clinical instability or lifethreatening disease
* Canadian Cardiovascular Society class IV angina
* nonevaluable CCTA as determined by the CCTA core laboratory
* Inability to adhere to study procedures

Primary outcomes:
measure: Diagnostic Accuracy of FFRCT
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic accuracy of FFRCT at the subject level
timeFrame: 1 day
measure: Diagnostic accuracy of FFRCT at the vessel level
timeFrame: 1 day
measure: FFR Numerical Correlation
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Shanghai Tenth People's Hospital
Study officials:
affiliation: Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
name: Ya-Wei Xu, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.
citation: Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.