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Association of T1-mapping and LV Strain Analysis by CMR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03405987
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Kammerlander, Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment
Myocardial Fibrosis Diagnostic Test: Strain analysis by CMR

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of T1-mapping and LV Strain Analysis by CMR
Actual Study Start Date : July 1, 2012
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Group/Cohort Intervention/treatment
ECV < median Diagnostic Test: Strain analysis by CMR
Strain analysis by CMR will be performed

ECV ≥ median Diagnostic Test: Strain analysis by CMR
Strain analysis by CMR will be performed




Primary Outcome Measures :
  1. Association of native LV T1-values and strain analysis [ Time Frame: Baseline ]
    Association of native LV T1-values and strain analysis by CMR

  2. Association of ECV and strain analysis [ Time Frame: Baseline ]
    Association of ECV and strain analysis by CMR

  3. Association of strain analysis and outcome [ Time Frame: 2 years ]
    Association of strain analysis by CMR and outcome (combination of cardiovascular hospitalization or death)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • undergoing CMR
  • willingness to participate

Exclusion Criteria:

  • <18 years old
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405987


Contacts
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Contact: Andreas Kammerlander, MD 014040046140 andreas.kammerlander@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Andreas Kammerlander, MD PhD         
Sponsors and Collaborators
Medical University of Vienna
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Responsible Party: Dr. Andreas Kammerlander, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03405987    
Other Study ID Numbers: T1-strain-2436
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes