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CompletedNCT02805621MachineUpdated Jan 4, 2017

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

An observational study in Coronary Heart Disease and Coronary Artery Disease, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-04.

Sponsored by Erasmus Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
352
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Coronary Heart Disease
  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 352 is close to the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
352 participants (actual)
Patient registry
No

Groups and cohorts

  • Subject

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

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What researchers measure

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

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Study locations

1 site
  • ErasmusMC
    Rotterdam, Zuid Holland 3015CE, Netherlands
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References and documents

Publications

  • De Geer J, Sandstedt M, Bjorkholm A, Alfredsson J, Janzon M, Engvall J, Persson A. Software-based on-site estimation of fractional flow reserve using standard coronary CT angiography data. Acta Radiol. 2016 Oct;57(10):1186-92. doi: 10.1177/0284185115622075. Epub 2015 Dec 20. PubMed 26691914 ↗
  • Kruk M, Wardziak L, Demkow M, Pleban W, Pregowski J, Dzielinska Z, Witulski M, Witkowski A, Ruzyllo W, Kepka C. Workstation-Based Calculation of CTA-Based FFR for Intermediate Stenosis. JACC Cardiovasc Imaging. 2016 Jun;9(6):690-9. doi: 10.1016/j.jcmg.2015.09.019. Epub 2016 Feb 17. PubMed 26897667 ↗
  • Baumann S, Wang R, Schoepf UJ, Steinberg DH, Spearman JV, Bayer RR 2nd, Hamm CW, Renker M. Coronary CT angiography-derived fractional flow reserve correlated with invasive fractional flow reserve measurements--initial experience with a novel physician-driven algorithm. Eur Radiol. 2015 Apr;25(4):1201-7. doi: 10.1007/s00330-014-3482-5. Epub 2014 Nov 18. PubMed 25403173 ↗
  • Coenen A, Lubbers MM, Kurata A, Kono A, Dedic A, Chelu RG, Dijkshoorn ML, Gijsen FJ, Ouhlous M, van Geuns RJ, Nieman K. Fractional flow reserve computed from noninvasive CT angiography data: diagnostic performance of an on-site clinician-operated computational fluid dynamics algorithm. Radiology. 2015 Mar;274(3):674-83. doi: 10.1148/radiol.14140992. Epub 2014 Oct 13. PubMed 25322342 ↗
  • Yang DH, Kim YH, Roh JH, Kang JW, Ahn JM, Kweon J, Lee JB, Choi SH, Shin ES, Park DW, Kang SJ, Lee SW, Lee CW, Park SW, Park SJ, Lim TH. Diagnostic performance of on-site CT-derived fractional flow reserve versus CT perfusion. Eur Heart J Cardiovasc Imaging. 2017 Apr 1;18(4):432-440. doi: 10.1093/ehjci/jew094. PubMed 27354345 ↗
  • Tesche C, Otani K, De Cecco CN, Coenen A, De Geer J, Kruk M, Kim YH, Albrecht MH, Baumann S, Renker M, Bayer RR, Duguay TM, Litwin SE, Varga-Szemes A, Steinberg DH, Yang DH, Kepka C, Persson A, Nieman K, Schoepf UJ. Influence of Coronary Calcium on Diagnostic Performance of Machine Learning CT-FFR: Results From MACHINE Registry. JACC Cardiovasc Imaging. 2020 Mar;13(3):760-770. doi: 10.1016/j.jcmg.2019.06.027. Epub 2019 Aug 14. PubMed 31422141 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02805621
Lead sponsor
Erasmus Medical Center
Collaborators
Asan Medical Center, University Hospital, Linkoeping, National Institute of Cardiology, Warsaw, Poland, Medical University of South Carolina, Siemens Healthcare Diagnostics Inc
Responsible party
Laurens Groenendijk (dr, Erasmus Medical Center) — Principal investigator
First posted
Jun 20, 2016
Start date
Apr 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jan 4, 2017

Study contacts

Koen Nieman, MD PHD
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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