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
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: FFR (PressureWire)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography

Resource links provided by NLM:


Further study details as provided by Shanghai 10th People's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: Ya-Wei Xu, MD,FACC, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT01747317     History of Changes
Other Study ID Numbers: TENTH1010
Study First Received: December 9, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on August 19, 2014