Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography (PERFECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT01747317
First received: December 9, 2012
Last updated: December 10, 2012
Last verified: December 2012

December 9, 2012
December 10, 2012
December 2012
March 2013   (final data collection date for primary outcome measure)
Diagnostic Accuracy of FFRCT [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01747317 on ClinicalTrials.gov Archive Site
  • Diagnostic accuracy of FFRCT at the subject level [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.
  • Diagnostic accuracy of FFRCT at the vessel level [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.
  • FFR Numerical Correlation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.
Same as current
Not Provided
Not Provided
 
Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography
Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography

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.

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

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
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.
Other Names:
  • PressureWire™ Certus(St. Jude Medical Systems)
  • PressureWire™ Certus(ComboWire, Volcano Corporation)
Experimental: Single arm study
Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm.
Intervention: Device: FFR (PressureWire)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
April 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01747317
TENTH1010
Yes
Ya-Wei Xu, Shanghai 10th People's Hospital
Shanghai 10th People's Hospital
Not Provided
Principal Investigator: Ya-Wei Xu, MD, FACC Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
Shanghai 10th People's Hospital
December 2012

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