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Status unknownNCT03405987Updated Mar 16, 2020

Association of T1-mapping and LV Strain Analysis by CMR

An observational study in Myocardial Fibrosis, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-16.

Sponsored by Medical University of Vienna · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Fibrosis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

  • undergoing CMR
  • willingness to participate

Exclusion criteria

Exclusion Criteria:

  • \<18 years old
  • pregnancy
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • ECV < median

    Diagnostic Test: Strain analysis by CMR

  • ECV ≥ median

    Diagnostic Test: Strain analysis by CMR

Interventions

  • Diagnostic testStrain analysis by CMR

    Strain analysis by CMR will be performed

05

What researchers measure

Primary outcomes

  1. Association of native LV T1-values and strain analysis

    Association of native LV T1-values and strain analysis by CMR

    Time frame: Baseline

  2. Association of ECV and strain analysis

    Association of ECV and strain analysis by CMR

    Time frame: Baseline

  3. Association of strain analysis and outcome

    Association of strain analysis by CMR and outcome (combination of cardiovascular hospitalization or death)

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Medical University of Vienna
    Vienna, 1090, Austria
    • Andreas Kammerlander, MD PhD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03405987
Lead sponsor
Medical University of Vienna
Responsible party
Dr. Andreas Kammerlander (MD, Medical University of Vienna) — Principal investigator
First posted
Jan 23, 2018
Start date
Jul 1, 2012
Primary completion
Dec 1, 2020 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Mar 16, 2020

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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