Machine leArning Based CT angiograpHy derIved FFR: a Multi-ceNtEr, Registry (Machine)

January 3, 2017 updated by: Laurens Groenendijk, Erasmus Medical Center

Machine leArning Based CT angiograpHy derIved FFR a Multi-ceNtEr, Registry

Demonstrate in a large multicenter population the diagnostic performance of a pre-commercial on-site, local, CT angiography derived FFR algorithm in comparison to invasive FFR.

Study Overview

Status

Completed

Conditions

Detailed Description

To retrospectively evaluate the diagnostic accuracy of FFRCT, in patients with known or suspected CAD. the investigators propose to do technical assessment of the software and evaluate how different parameters effect the outcome. Validate the FFTCT outcome by comparing the FFRCT values with invasive FFR values from retrospective patient data. To analyze the potential of FFRCT on decision making and prognosis.

Study Type

Observational

Enrollment (Actual)

352

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

  • Netherlands
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3015CE
        • ErasmusMC

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

Sampling Method

Non-Probability Sample

Study Population

In general, each center used its own specific inclusion and exclusion criteria. Here the investigators describe the general criteria, please see the respected publications for a detailed description.1-4

Description

Inclusion Criteria:

  • Know or suspect coronary artery disease followed within 6 months by an invasive FFR measurement.

Exclusion Criteria:

  • Cardiac event between coronary CT angiography and the invasive FFR procedure, noninterpretable coronary CT angiography image quality, or incomplete coronary CT angiography coverage.

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

Cohorts and Interventions

Group / Cohort
Subject
Patients with know or suspected coronary artery disease, who underwent both CT angiography and invasive coronary angiography including invasive FFR measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of local reduced order CFD and machine learning based CT angiography derived FFR, both validated against invasive FFR. Measured at both vessel and patient level.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence of calcium on diagnostic accuracy of CT angiography derived FFR.
Time Frame: 6 months
6 months
Confidence intervals of CT angiography derived FFR
Time Frame: 6 months
6 months
Direct vessel based comparison between CT angiography derived FFR and QCT stenosis measurements
Time Frame: 6 months
6 months
Analysis of anatomically mild stenosis (<50% lumen diameter reduction) but functionally significant (invasive FFR ≤ 0.80)
Time Frame: 6 months
6 months
Long term clinical outcome of CT angiography derived FFR
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Erasmus Medical Center

Collaborators

Medical University of South Carolina
Asan Medical Center
Institute of Cardiology, Warsaw, Poland
University Hospital, Linkoeping
Siemens Healthcare Diagnostics Inc

Investigators

  • Principal Investigator: Koen Nieman, MD PHD, Erasmus Medical Center

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

April 1, 2016

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (ESTIMATE)

June 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Machine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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