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

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ClinicalTrials.gov Identifier: NCT01747317
Recruitment Status : Unknown
Verified December 2012 by Ya-Wei Xu, Shanghai 10th People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: FFR (PressureWire) Phase 4

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography
Study Start Date : December 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm study
Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm.
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)




Primary Outcome Measures :
  1. Diagnostic Accuracy of FFRCT [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Diagnostic accuracy of FFRCT at the subject level [ Time Frame: 1 day ]
    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.

  2. Diagnostic accuracy of FFRCT at the vessel level [ Time Frame: 1 day ]
    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.

  3. FFR Numerical Correlation [ Time Frame: 1 day ]
    Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747317


Locations
China
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
Principal Investigator: Ya-Wei Xu, MD, FACC Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine

Additional Information:
Publications of Results:
Responsible Party: Ya-Wei Xu, MD,FACC, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT01747317     History of Changes
Other Study ID Numbers: TENTH1010
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
FFR
fractional flow reserve
CT
Computed Tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases