Back to resultsEvaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gated Stationary Chest Tomosynthesis
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Age range: ≥18 years of age
- Intermediate Framingham Risk Score of 10 to 20% risk over the next 10 years
- Previous non-contrast enhanced chest CT in a time frame that will accommodate experimental imaging (CG-SDCT) within 4 weeks. This imaging may have already been completed at the time of enrollment or may be scheduled in the future at the time of enrollment.
- IRB written informed consent obtained and signed Exclusion Criteria
- Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT.
Exclusion Criteria:
- Unable to provide consent
- Pregnant or lactating
- BMI > 33 (Patient who may not fit on a 35 x 35 detector) (Images are not clear on subjects who have a greater than 33 BMI)
- Previous history of MI or thoracic surgery.
- Disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds.
- Planned procedures or therapies in between non-contrast CT scan and study Chest tomosynthesis scan, e.g., line placement in the chest region, biopsy, etc.
Sites / Locations
- University of North Carolina of Chapel hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients
Arm Description
Gated Stationary Chest Tomosynthesis
Outcomes
Primary Outcome Measures
Comparison of CT Derived CACS and Tomosynthesis Scores Correlation
Linear regression and Bland-Altman analysis will be used to examine the relationship between the CT derived CACS and tomosynthesis scores to determine the correlation
Secondary Outcome Measures
Mean Correlation Coefficient of Gating
The 30 ms cardiac EKG trace will be extracted for each of the projections. Then, a Pearson correlation coefficient will be calculated for each of the projections relative to the first x-ray projection. The mean of the Pearson correlation coefficients will then calculated and served as an estimate of the timing precision of each projection set for each patient. The mean and standard deviation of the correlation coefficients will be reported.
Full Information
NCT ID
NCT03169062
First Posted
May 23, 2017
Last Updated
January 28, 2020
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT03169062
Brief Title
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
Official Title
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.
Detailed Description
The proposed research, if successfully implemented, will result in a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease. Using the Cardiac Gated Stationary Chest Tomosynthesis (CG-SDCT) system the imaging dose for a a full tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The targeted imaging time of 25-30 seconds is 1/2 of that from a current commercial DCT system at the same imaging dose. As with current commercial DCT systems, our s-DCT system will expose patients to less radiation and deliver comparable data for CACS. CG-SDCT will likely result in accurate CAC scoring and allow for a more complete patient risk assessment as compared to Framingham risk scoring alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Experimental
Arm Description
Gated Stationary Chest Tomosynthesis
Intervention Type
Device
Intervention Name(s)
Gated Stationary Chest Tomosynthesis
Intervention Description
The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes.
Primary Outcome Measure Information:
Title
Comparison of CT Derived CACS and Tomosynthesis Scores Correlation
Description
Linear regression and Bland-Altman analysis will be used to examine the relationship between the CT derived CACS and tomosynthesis scores to determine the correlation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mean Correlation Coefficient of Gating
Description
The 30 ms cardiac EKG trace will be extracted for each of the projections. Then, a Pearson correlation coefficient will be calculated for each of the projections relative to the first x-ray projection. The mean of the Pearson correlation coefficients will then calculated and served as an estimate of the timing precision of each projection set for each patient. The mean and standard deviation of the correlation coefficients will be reported.
Time Frame
At the conclusion of all data collection, 6 months post study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range: ≥18 years of age
Intermediate Framingham Risk Score of 10 to 20% risk over the next 10 years
Previous non-contrast enhanced chest CT in a time frame that will accommodate experimental imaging (CG-SDCT) within 4 weeks. This imaging may have already been completed at the time of enrollment or may be scheduled in the future at the time of enrollment.
IRB written informed consent obtained and signed Exclusion Criteria
Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT.
Exclusion Criteria:
Unable to provide consent
Pregnant or lactating
BMI > 33 (Patient who may not fit on a 35 x 35 detector) (Images are not clear on subjects who have a greater than 33 BMI)
Previous history of MI or thoracic surgery.
Disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds.
Planned procedures or therapies in between non-contrast CT scan and study Chest tomosynthesis scan, e.g., line placement in the chest region, biopsy, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueh Lee, M.D
Organizational Affiliation
University of North Carolina of Chapel hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina of Chapel hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7510
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
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