Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography

NCT01747317 | Unknown Phase 4 DMC

• 1 other identifier: TENTH1010
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

FFR; fractional flow reserve; CT; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Diagnostic accuracy of FFRCT at the subject level

  1 day

• Diagnostic accuracy of FFRCT at the vessel level

  1 day

• FFR Numerical Correlation

  1 day

Study Arms (1)

Single arm study

EXPERIMENTAL

Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm.

Device: FFR (PressureWire)

Interventions

FFR (PressureWire) DEVICE

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.

Also known as: PressureWire™ Certus(St. Jude Medical Systems), PressureWire™ Certus(ComboWire, Volcano Corporation)

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

Related 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. 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.

  PMID: 22032711 RESULT

• 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.

  PMID: 22922562 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ya-Wei Xu, MD, FACC

  Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,FACC

Study Record Dates

• First Submitted: December 9, 2012
• First Posted: December 11, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

CN (1)