Skip to main content
OpenTrials
Completed

NCT Number: NCT02805621

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ErasmusMC

Rotterdam, South Holland, 3015CE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Influence of calcium on diagnostic accuracy of CT angiography derived FFR.

    Time frame: 6 months

  2. Confidence intervals of CT angiography derived FFR

    Time frame: 6 months

  3. Direct vessel based comparison between CT angiography derived FFR and QCT stenosis measurements

    Time frame: 6 months

  4. Analysis of anatomically mild stenosis (<50% lumen diameter reduction) but functionally significant (invasive FFR ≤ 0.80)

    Time frame: 6 months

  5. Long term clinical outcome of CT angiography derived FFR

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Machine

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2016
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.