NCT04220450

Brief Summary

On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 5, 2020

Last Update Submit

January 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation NAFLD and liver T1mapping

    Correlation NAFLD risk score and liver T1-mapping (native and ECV9

    cross-sectional within one year

Interventions

On clinically indicated Cardiovascular Magnetic Resonance Imaging Studies, native T1-times and extracellular volume will be determined

Eligibility Criteria

Age18 Months+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All-comer cohort referred for Cardiovascular Magnetic Resonance Imaging

You may qualify if:

  • Referred for Cardiovascular Magnetic Resonance Imaging

You may not qualify if:

  • Non-compatible Devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Mascherbauer K, Dona C, Koschutnik M, Dannenberg V, Nitsche C, Duca F, Heitzinger G, Halavina K, Steinacher E, Kronberger C, Bardach C, Beitzke D, Loewe C, Waldmann E, Trauner M, Barkto P, Goliasch G, Mascherbauer J, Hengstenberg C, Kammerlander A. Hepatic T1-Time Predicts Cardiovascular Risk in All-Comers Referred for Cardiovascular Magnetic Resonance: A Post-Hoc Analysis. Circ Cardiovasc Imaging. 2022 Oct;15(10):e014716. doi: 10.1161/CIRCIMAGING.122.014716. Epub 2022 Oct 18.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseHeart FailureCoronary Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 15, 2021

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations