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

NCT ID: NCT02805621

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

352 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Heart Disease Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subject

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

Siemens Healthcare Diagnostics Inc

INDUSTRY

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Laurens Groenendijk

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koen Nieman, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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ErasmusMC

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 26691914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26897667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25403173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25322342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27354345 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31422141 (View on PubMed)

Other Identifiers

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Machine

Identifier Type: -

Identifier Source: org_study_id

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