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Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.

NCT ID: NCT03149042

Last Updated: 2020-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-28

Study Completion Date

2019-04-21

Brief Summary

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Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-center clinical trials. Using patient specific 3D printed coronary phantoms would allow optimization of FFR-CT algorithms with a measured validation technique without the need for large clinical trials. Thus the investigators believe that this study will result in a FFR-CT algorithm/method with a better predictability for arterial lesion severity than those existing on the market today. Flow measurements will be compared with: CT-FFR for both patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical study includes \~50 patients over a year and half at GVI.

Detailed Description

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Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Following this trend, the investigators recently developed a collaboration between Brigham and Women's Hospital (BWH) and Gates Vascular Institute (GVI). The investigators 3D-printed patient specific coronary phantoms at (GVI) and scanned them with a Toshiba Aquilion scanner to test several aspects of the contrast opacification gradients using a method established at BWH. The initial results showed strong correlation between the flow in the phantom and opacification gradients. The investigators believe that this approach could be further developed to test and validate FFR-CT algorithms. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-center clinical trials. This phantom approach would allow optimization of FFR-CT algorithms with a measured validation technique without the need for large clinical trials. Thus the investigators believe that this study will result in a FFR-CT algorithm/method with a better predictability for arterial lesion severity than those existing on the market today. The approach is to use the infrastructure at GVI to perform a detailed validation of the FFR-CT method using 3D printed patient specific phantoms. The subject enrollment criteria is: at least one CCTA, at least one lesion with \>50% stenosis or 30-50% and an angio based FFR. Each patient will have a 3D phantom printed, containing the culprit lesion and used in a benchtop flow analysis. Flow measurements will be compared with: CT-FFR for both patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical study will include \~50 patients over a year and half at GVI. The investigators are confident that this approach performed via 3D-phantom testing will prove the validity of FFR-CT based measurements as well as develop a new standard for validating FFR-CT algorithms.

Conditions

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Atherosclerosis, Coronary

Keywords

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FFR Fractional Flow Reserve Atherosclerosis Coronary stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CCTA

Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital.

CCTA

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test

Interventions

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CCTA

Diagnostic Test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All the patients \>18 yrs of age , who are undergoing CCTA and angio-FFR. Patients who are (1) scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital or (2) clinically mandated CTA will be screened.

Exclusion Criteria

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* atrial fibrillation,
* Renal insufficiency (estimated glomerular filtration rate (GFR) \<60 ml/min/1.73 m2),
* Active Bronchospasm prohibiting the use of beta blockers
* Morbid obesity (body mass index 40 kg/m2)
* Contraindications to iodinated contrast.
* Emergencies requiring immediate intervention or patients unable to consent.
* Patients not showing coronary calcium during Calcium Scoring procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Ciprian Ionita

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical and Translational Research Center Room 8052

Buffalo, New York, United States

Site Status

Countries

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United States

References

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Sommer K, Izzo RL, Shepard L, Podgorsak AR, Rudin S, Siddiqui AH, Wilson MF, Angel E, Said Z, Springer M, Ionita CN. Design Optimization for Accurate Flow Simulations in 3D Printed Vascular Phantoms Derived from Computed Tomography Angiography. Proc SPIE Int Soc Opt Eng. 2017 Feb 11;10138:101380R. doi: 10.1117/12.2253711. Epub 2017 Mar 13.

Reference Type BACKGROUND
PMID: 28663663 (View on PubMed)

Ionita, C., Angel, E., Mitsouras, D., Rudin, S., Bednarek, D., Zaid, S., Wilson, M. and Rybicki, F. (2016), TU-H-CAMPUS-IeP2-03: Development of 3D Printed Coronary Phantoms for In-Vitro CT-FFR Validation Using Data from 320- Detector Row Coronary CT Angiography. Med. Phys., 43: 3781. doi:10.1118/1.4957681

Reference Type BACKGROUND

Kelsey N. Sommer, Lauren M. Shepard, Vijay Iyer, Erin Angel, Michael F. Wilson, Frank J. Rybicki, Dimitrios Mitsouras, Kanako Kunishima Kumamaru, Stephen Rudin, and Ciprian N. Ionita. Comparison of benchtop pressure gradient measurements in 3D printed patient specific cardiac phantoms with CT-FFR and computational fluid dynamic simulations, Proc. SPIE 10953, Medical Imaging 2019: Biomedical Applications in Molecular, Structural, and Functional Imaging, 109531P (15 March 2019);

Reference Type BACKGROUND

Shepard LM, Sommer KN, Angel E, Iyer V, Wilson MF, Rybicki FJ, Mitsouras D, Molloi S, Ionita CN. Initial evaluation of three-dimensionally printed patient-specific coronary phantoms for CT-FFR software validation. J Med Imaging (Bellingham). 2019 Apr;6(2):021603. doi: 10.1117/1.JMI.6.2.021603. Epub 2019 Mar 12.

Reference Type BACKGROUND
PMID: 30891468 (View on PubMed)

Sommer KN, Shepard L, Karkhanis NV, Iyer V, Angel E, Wilson MF, Rybicki FJ, Mitsouras D, Rudin S, Ionita CN. 3D Printed Cardiovascular Patient Specific Phantoms Used for Clinical Validation of a CT-derived FFR Diagnostic Software. Proc SPIE Int Soc Opt Eng. 2018 Feb;10578:105780J. doi: 10.1117/12.2292736. Epub 2018 Mar 12.

Reference Type BACKGROUND
PMID: 29899591 (View on PubMed)

Shepard L, Sommer K, Izzo R, Podgorsak A, Wilson M, Said Z, Rybicki FJ, Mitsouras D, Rudin S, Angel E, Ionita CN. Initial Simulated FFR Investigation Using Flow Measurements in Patient-specific 3D Printed Coronary Phantoms. Proc SPIE Int Soc Opt Eng. 2017 Feb 11;10138:101380S. doi: 10.1117/12.2253889. Epub 2017 Mar 13.

Reference Type BACKGROUND
PMID: 28649159 (View on PubMed)

Kelsey N. Sommer, Lauren M. Shepard, Vijay Iyer, Erin Angel, Michael F. Wilson, Frank J. Rybicki, Dimitrios Mitsouras, Ciprian Ionita. Study of the effect of boundary conditions on fractional flow reserve using patient specific coronary phantoms. Proceedings Volume 11317, Medical Imaging 2020: Biomedical Applications in Molecular, Structural, and Functional Imaging; 113171J (2020) https://doi.org/10.1117/12.2548472

Reference Type BACKGROUND

Sommer KN, Shepard LM, Mitsouras D, Iyer V, Angel E, Wilson MF, Rybicki FJ, Kumamaru KK, Sharma UC, Reddy A, Fujimoto S, Ionita CN. Patient-specific 3D-printed coronary models based on coronary computed tomography angiography volumes to investigate flow conditions in coronary artery disease. Biomed Phys Eng Express. 2020 May 14;6(4):045007. doi: 10.1088/2057-1976/ab8f6e.

Reference Type RESULT
PMID: 33444268 (View on PubMed)

Kumamaru KK, Angel E, Sommer KN, Iyer V, Wilson MF, Agrawal N, Bhardwaj A, Kattel SB, Kondziela S, Malhotra S, Manion C, Pogorzelski K, Ramanan T, Sawant AC, Suplicki MM, Waheed S, Fujimoto S, Sharma UC, Rybicki FJ, Ionita CN. Inter- and Intraoperator Variability in Measurement of On-Site CT-derived Fractional Flow Reserve Based on Structural and Fluid Analysis: A Comprehensive Analysis. Radiol Cardiothorac Imaging. 2019 Aug 29;1(3):e180012. doi: 10.1148/ryct.2019180012. eCollection 2019 Aug.

Reference Type RESULT
PMID: 33778507 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://iopscience.iop.org/article/10.1088/2057-1976/ab8f6e/meta

results

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id