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

December 10, 2012 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200072
        • Department of Cardiology, Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

December 9, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 10, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENTH1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on FFR (PressureWire)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe