Reduced Radiation Dose and IR-impact on Coronary Calcium... | NCT04267094

Studies
Reduced Radiation Dose and IR-impact on Coronary Calcium Quantification

NCT04267094

Sponsor

University of Pennsylvania

Status

Terminated

Last Update Posted

Mar 7, 2024Actual

Enrollment

190Actual

Phase

Not Applicable

Conditions

Atherosclerotic Plaque

Interventions

Iterative reconstruction at reduced radiation dose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Science has changed

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Mar 7, 2023Actual

Completion Date

Mar 7, 2023Actual

First Submitted Date

Feb 10, 2020

First Submission Date that Met QC Criteria

Feb 10, 2020

First Posted Date

Feb 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Harold Litt, MD, PhD, Associate Professor of Radiology, University of PennsylvaniaPrincipal Investigator

Lead Sponsor

University of PennsylvaniaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iterative reconstruction at reduced radiation dose	Device	Evaluating Agatston coronary calcium score using reduced dose acquisitions reconstructed using iterative reconstruction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Calcium score	Calcium score compared to FBP full dose recon	immediate

Secondary Outcomes

Measure	Description	Time Frame
Risk stratification	Cardiovascular risk stratification group of reduced dose IR vs. full dose FBP	immediate

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

Submission Tracking

Estimated Results First Submitted Date

Apr 8, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 8, 2024			May 2, 2024	5
Oct 8, 2024

Condition Browse Module

MeSH Terms

ID	Term
D058226	Plaque, Atherosclerotic

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided