NCT04267094

Brief Summary

Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

5.7 years

First QC Date

February 10, 2020

Last Update Submit

March 5, 2024

Conditions

Atherosclerotic Plaque

Outcome Measures

Primary Outcomes (1)

  • Calcium score

    Calcium score compared to FBP full dose recon

    immediate

Secondary Outcomes (1)

  • Risk stratification

    immediate

Interventions

Iterative reconstruction at reduced radiation doseDEVICE

Evaluating Agatston coronary calcium score using reduced dose acquisitions reconstructed using iterative reconstruction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing routine calcium scoring CT at facilities at the University of Pennsylvania

You may not qualify if:

  • Patients found to have no coronary calcium on full dose FBP reconstructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

July 1, 2017

Primary Completion

March 7, 2023

Study Completion

March 7, 2023

Last Updated

March 7, 2024

Record last verified: 2024-03

Locations

US(1)