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Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography

NCT ID: NCT01747317

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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

Conditions

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Coronary Artery Disease

Keywords

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FFR fractional flow reserve CT Computed Tomography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm study

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

Group Type EXPERIMENTAL

FFR (PressureWire)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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PressureWire™ Certus(St. Jude Medical Systems) PressureWire™ Certus(ComboWire, Volcano Corporation)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

MD,FACC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ya-Wei Xu, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 22032711 (View on PubMed)

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.

Reference Type RESULT
PMID: 22922562 (View on PubMed)

Other Identifiers

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TENTH1010

Identifier Type: -

Identifier Source: org_study_id