Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography

Coronary Artery Disease Clinical Trial

— PERFECT  

Official title:

Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01747317
• Other study ID #: TENTH1010
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 9, 2012
• Last updated: December 10, 2012
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2012
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• FFR (PressureWire)
Fractional flow reserve measured during cardiac catheterization——A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden;ComboWire, Volcano Corporation, San Diego, California) will be advanced past the stenosis.

Locations

Country	Name	City	State
China	Department of Cardiology, Shanghai Tenth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Resu — View 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 reser — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy of FFRCT	Diagnostic accuracy[Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)]* of FFRCT to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis at the subject level using binary outcomes when compared to FFR as the reference standard..*Sensitivity measures the proportion of actual positives which are correctly identified. Specificity measures the proportion of negatives which are correctly identified;PPV, or precision rate is the proportion of positive test results that are true positives (such as correct diagnoses);NPV is defined as the proportion of subjects with a negative test result who are correctly diagnosed.	1 day	No
Secondary	Diagnostic accuracy of FFRCT at the subject level	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FFRCT at the subject level using binary outcomes when compared to FFR as the reference standard.	1 day	No
Secondary	Diagnostic accuracy of FFRCT at the vessel level	Sensitivity, specificity, PPV and NPV of FFRCT for the presence or absence of HD-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.	1 day	No
Secondary	FFR Numerical Correlation	Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.	1 day	No

External Links

•   Shanghai Tenth People's Hospital