Back to resultsReduced Radiation Dose and IR-impact on Coronary Calcium Quantification
Primary Purpose
Atherosclerotic Plaque
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iterative reconstruction at reduced radiation dose
Sponsored by
About this trial
This is an interventional diagnostic trial for Atherosclerotic Plaque
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing routine calcium scoring CT at facilities at the University of Pennsylvania
Exclusion Criteria:
- Patients found to have no coronary calcium on full dose FBP reconstructions
Sites / Locations
- University of Pennsylvania
Outcomes
Primary Outcome Measures
Calcium score
Calcium score compared to FBP full dose recon
Secondary Outcome Measures
Risk stratification
Cardiovascular risk stratification group of reduced dose IR vs. full dose FBP
Full Information
NCT ID
NCT04267094
First Posted
February 10, 2020
Last Updated
June 12, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04267094
Brief Title
Reduced Radiation Dose and IR-impact on Coronary Calcium Quantification
Official Title
A Single-center, Multi-scanner, Observational Study to Investigate the Impact of Reduced Radiation Dose and Iterative Reconstruction Algorithms on Coronary Calcium Score in Comparison to the Standard Normal Radiation Dose -Filtered Back Projection Method
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
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
5. Study Description
Brief Summary
Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Plaque
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Iterative reconstruction at reduced radiation dose
Intervention Description
Evaluating Agatston coronary calcium score using reduced dose acquisitions reconstructed using iterative reconstruction
Primary Outcome Measure Information:
Title
Calcium score
Description
Calcium score compared to FBP full dose recon
Time Frame
immediate
Secondary Outcome Measure Information:
Title
Risk stratification
Description
Cardiovascular risk stratification group of reduced dose IR vs. full dose FBP
Time Frame
immediate
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing routine calcium scoring CT at facilities at the University of Pennsylvania
Exclusion Criteria:
Patients found to have no coronary calcium on full dose FBP reconstructions
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reduced Radiation Dose and IR-impact on Coronary Calcium Quantification
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