Fluid Status and T1-mapping by CMR (BCM-CMR-T1)

August 12, 2019 updated by: Dr. Andreas Kammerlander, Medical University of Vienna

Fluid Status Assessed by Bioelectrical Impedance Spectroscopy and Its Association With T1-mapping by Cardiovascular Magnetic Resonance Imaging

It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging.

In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Andreas Kammerlander, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing cardiovascular magnetic resonance imaging including T1-mapping are invited to participate in the study where fluid status will be assessed by bioimpedance spectroscopy right before cardiovascular magnetic resonance imaging.

Description

Inclusion Criteria:

  • written informed consent
  • patient undergoing cardiovascular magnetic resonance imaging

Exclusion Criteria:

  • Unwillingness to participate
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fluid overload (Liters) ≥ median
Diagnostic test: Bioimpedance spectroscopy
Fluid overload will be assessed by bioimpedance spectroscopy
Other Names:
  • BCM measurement
Fluid overload (Liters) < median
Diagnostic test: Bioimpedance spectroscopy
Fluid overload will be assessed by bioimpedance spectroscopy
Other Names:
  • BCM measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Native T1-mapping
Time Frame: baseline
Association of fluid overload and native T1 values of left ventricular myocardium
baseline
Extracellular Volume by Cardiovascular magnetic resonance imaging
Time Frame: baseline
Association of fluid overload and extracellular volume of left ventricular myocardium
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2018

Primary Completion (Anticipated)

December 15, 2020

Study Completion (Anticipated)

December 15, 2020

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCM-CMR-T1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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