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

November 15, 2020 updated by: Ciprian Ionita, State University of New York at Buffalo
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14021
        • Clinical and Translational Research Center Room 8052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are (1) scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital or Juntendo Hospital Japan (2) clinically mandated CTA will be screened.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CCTA
Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital.
Diagnostic test: CCTA
Diagnostic Test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of CT Based FFR With Invasive FFR, ROC Analysis
Time Frame: 24 hours

Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion.

Area under the Receiver Operator Characteristic were measured where an Invasive FFR<=0.8 was considered positive.
24 hours
Comparison of CT Based FFR With Invasive FFR, Correlation Analysis
Time Frame: 24 hours

Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion.

Pearson Correlation between Invasive FFR and CT based FFR was measured
24 hours
Comparison of CT Based FFR With Invasive FFR, Sensitivity
Time Frame: 24 hours

Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion.

Sensitivity were measured where an Invasive FFR<=0.8 was considered positive. Sensitivity reflects the percentage of true positive cases identified by CT-FFR compared to I-FFR
24 hours
Comparison of CT Based FFR With Invasive FFR, Specificity
Time Frame: 24 hours

Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion.

Specificity was measured, where an Invasive FFR<=0.8 was considered positive. Specificity reflects the percentage of true negative cases identified by CT-FFR compared to I-FFR
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of CT Based FFR With Bench-top FFR Using 3D Printed Patient Specific Phantoms
Time Frame: 4 weeks from baseline
CT images were used to measure CT-FFR and to generate patient-specific 3D printed models of the aortic root and three main coronary arteries. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and bench-top FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Linear regression and Pearson correlation was calculated.
4 weeks from baseline
Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, ROC Analysis
Time Frame: 4 weeks from baseline
CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Area under the Receiver Operator Characteristic were measured where an Invasive FFR<=0.8 was considered positive.
4 weeks from baseline
Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Pearson Correlation
Time Frame: 4 weeks from baseline
CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Pearson Correlation factor was calculated.
4 weeks from baseline
Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Sensitivity
Time Frame: 4 weeks from baseline
CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Sensitivity was measure, where an Invasive FFR<=0.8 was considered positive.Sensitivity reflects the percentage of true positive cases identified by B-FFR compared to I-FFR
4 weeks from baseline
Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Specificity
Time Frame: 4 weeks from baseline
CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Specificity was calculated, where an Invasive FFR<=0.8 was considered positive. Specificity reflects the percentage of true negative cases identified by B-FFR compared to I-FFR
4 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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