Coronary Heart DiseaseMachineNCT02805621

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

An observational study of Coronary Heart Disease and Coronary Artery Disease, run by Erasmus Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Heart Disease, Coronary Artery Disease
How many people: 352 participants
Where: 1 siteNetherlands
Study dates: Apr 2016to Jan 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

ErasmusMC
Rotterdam, South Holland, 3015CE

Other trials in Netherlands

About this study

Official title: 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.

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.

Conditions: Coronary Heart Disease, Coronary Artery Disease
Medical subject headings: Coronary Disease, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02805621
Study group	Role	What they receive
Subject		Patients with know or suspected coronary artery disease, who underwent both CT angiography and invasive coronary angiography including invasive FFR measurements.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Jan 2017

First posted20 Jun 2016 (estimated)
Study startApr 2016
Primary completionJan 2017
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 352 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02805621
Sponsor's protocol ID: Machine
Acronym: Machine
Status last verified: Jan 2017
First submitted: 15 Jun 2016
Last updated: 4 Jan 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Machine leArning Based CT angiograpHy derIved FFR a Multi-ceNtEr, Registry
ClinicalTrials.gov ID: NCT02805621
Acronym / sponsor ID: Machine / Machine
Conditions: Coronary Heart Disease, Coronary Artery Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 352 participants (actual)
Lead sponsor: Erasmus Medical CenterUniversity, hospital or other
Collaborators: Asan Medical Center, University Hospital, Linkoeping, National Institute of Cardiology, Warsaw, Poland, Medical University of South Carolina, Siemens Healthcare Diagnostics Inc
Study start: Apr 2016
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 20 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
Background: PubMed 26691914De 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.
Background: PubMed 26897667Kruk 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.
Background: PubMed 25403173Baumann 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.
Background: PubMed 25322342Coenen 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.
Background: PubMed 27354345Yang 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.
Derived from this study: PubMed 31422141Tesche 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.
Individual participant dataSharing planned: No

Related trials for Coronary Heart Disease

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RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Koen Nieman, MD PHD principal investigator

Erasmus Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease and Coronary Artery Disease, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02805621, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.