- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405987
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
Intervention / Treatment
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.
Sponsor
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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