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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
FFR (PressureWire)
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring FFR, fractional flow reserve, CT, Computed Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Shanghai Tenth People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Diagnostic accuracy of FFRCT at the subject level
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
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
Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.

Full Information

First Posted
December 9, 2012
Last Updated
December 10, 2012
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01747317
Brief Title
Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography
Acronym
PERFECT
Official Title
Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
FFR, fractional flow reserve, CT, Computed Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Arm Description
Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm.
Intervention Type
Device
Intervention Name(s)
FFR (PressureWire)
Other Intervention Name(s)
PressureWire™ Certus(St. Jude Medical Systems), PressureWire™ Certus(ComboWire, Volcano Corporation)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic Accuracy of FFRCT
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Diagnostic accuracy of FFRCT at the subject level
Description
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.
Time Frame
1 day
Title
Diagnostic accuracy of FFRCT at the vessel level
Description
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.
Time Frame
1 day
Title
FFR Numerical Correlation
Description
Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Wei Xu, MD, FACC
Organizational Affiliation
Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Shanghai Tenth People's Hospital
City
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22032711
Citation
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.
Results Reference
result
PubMed Identifier
22922562
Citation
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.
Results Reference
result

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Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography

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