Impact of Fluid Status on Liver Elastography and T1-mappi... | NCT05239260

Studies
Impact of Fluid Status on Liver Elastography and T1-mapping Results in Patients Undergoing CMR.

NCT05239260

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Feb 14, 2022Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

NAFLD/MAFLD
Liver Fibrosis
CMR

Interventions

Countries

Austria

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

May 1, 2022Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Feb 5, 2022

First Submission Date that Met QC Criteria

Feb 5, 2022

First Posted Date

Feb 14, 2022Actual

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

Feb 5, 2022

Last Update Posted Date

Feb 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Andreas Kammerlander, MD Phd, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Correlation between CMR T1-times, liver T1-times, fibroscan and fluid status to identify the correlation and pathogenesis of liver disease in patients with heart disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CMR	Diagnostic Test	CMR		Fibroscan Body composition monitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of fluid status on liver elastography and T1-times		5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referred for Cardiovascular Magnetic Resonance Imaging

Exclusion Criteria:

Non-compatible Devices

Accepts Healthy Volunteers

Yes

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

All-comer cohort referred for Cardiovascular Magnetic Resonance Imaging

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katharina Mascherbauer	Contact	0043 1 40400 48590		katharina.mascherbauer@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Andreas Kammerlander	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Vienna	Recruiting	Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided