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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02805621

Acronym

Machine

Enrollment

352

Registered

2016-06-20

Start date

2016-04-30

Completion date

2017-01-31

Last updated

2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Heart Disease

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	6 months

Secondary

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

Countries

Netherlands

Outcome results