Association of T1-mapping and LV Strain Analysis by CMR

March 12, 2020 updated by: Dr. Andreas Kammerlander, Medical University of Vienna
The association of T1-mapping (both native and ECV) and strain analysis of LV and RV by CMR will be assessed. Results from strain analysis will be investigated in terms of their prognostic value.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Locations

      • 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 CMR for whatever reason will be invited to participate. A specific subgroup of patients are heart failure with preserved ejection fraction.

Description

Inclusion Criteria:

  • undergoing CMR
  • willingness to participate

Exclusion Criteria:

  • <18 years old
  • 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
ECV < median
Strain analysis by CMR will be performed
ECV ≥ median
Strain analysis by CMR will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of native LV T1-values and strain analysis
Time Frame: Baseline
Association of native LV T1-values and strain analysis by CMR
Baseline
Association of ECV and strain analysis
Time Frame: Baseline
Association of ECV and strain analysis by CMR
Baseline
Association of strain analysis and outcome
Time Frame: 2 years
Association of strain analysis by CMR and outcome (combination of cardiovascular hospitalization or death)
2 years

Collaborators and Investigators

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

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)

July 1, 2012

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 14, 2018

First Submitted That Met QC Criteria

January 14, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1-strain-2436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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