Reduced Radiation Dose and IR-impact on Coronary Calcium Quantification
Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04267094
Collaborator
(none)
190
1
54
3.5
Study Details
Study Description
Brief Summary
Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
190 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date
:
Jul 1, 2017
Anticipated Primary Completion Date
:
Dec 31, 2021
Anticipated Study Completion Date
:
Dec 31, 2021
Outcome Measures
Primary Outcome Measures
- Calcium score [immediate]
Calcium score compared to FBP full dose recon
Secondary Outcome Measures
- Risk stratification [immediate]
Cardiovascular risk stratification group of reduced dose IR vs. full dose FBP
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Harold Litt, MD, PhD,
Associate Professor of Radiology,
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04267094
Other Study ID Numbers:
- 824735
First Posted:
Feb 12, 2020
Last Update Posted:
Nov 4, 2020
Last Verified:
Nov 1, 2020
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
Additional relevant MeSH terms: