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

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ClinicalTrials.gov Identifier: NCT02805621
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
Asan Medical Center
University Hospital, Linkoeping
Institute of Cardiology, Warsaw, Poland
Medical University of South Carolina
Siemens Healthcare Diagnostics Inc
Information provided by (Responsible Party):
Laurens Groenendijk, Erasmus Medical Center

Brief Summary:
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.

Condition or disease
Coronary Heart Disease Coronary Artery Disease

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.

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Study Type : Observational
Actual Enrollment : 352 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Machine leArning Based CT angiograpHy derIved FFR a Multi-ceNtEr, Registry
Study Start Date : April 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805621


Locations
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Netherlands
ErasmusMC
Rotterdam, Zuid Holland, Netherlands, 3015CE
Sponsors and Collaborators
Erasmus Medical Center
Asan Medical Center
University Hospital, Linkoeping
Institute of Cardiology, Warsaw, Poland
Medical University of South Carolina
Siemens Healthcare Diagnostics Inc
Investigators
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Principal Investigator: Koen Nieman, MD PHD Erasmus Medical Center

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laurens Groenendijk, dr, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02805621    
Other Study ID Numbers: Machine
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases