Myocardial FibrosisNCT03405987
Association of T1-mapping and LV Strain Analysis by CMR
An observational study of Myocardial Fibrosis, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Fibrosis
- What is being tested?
- Strain analysis by CMR
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2012to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- undergoing CMR
- willingness to participate
Who cannot join
- <18 years old
- pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Andreas Kammerlander, MD PhD
About this study
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.
- Conditions
- Myocardial Fibrosis
- Being tested
- Strain analysis by CMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain analysis by CMRDiagnostic test
Strain analysis by CMR will be performed
| Study group | Role | What they receive |
|---|---|---|
| ECV < median | Not described Receives: Diagnostic Test: Strain analysis by CMR | |
| ECV ≥ median | Not described Receives: Diagnostic Test: Strain analysis by CMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of native LV T1-values and strain analysis
Association of native LV T1-values and strain analysis by CMR
Measured: Baseline
Association of ECV and strain analysis
Association of ECV and strain analysis by CMR
Measured: Baseline
Association of strain analysis and outcome
Association of strain analysis by CMR and outcome (combination of cardiovascular hospitalization or death)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jul 2012
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial FibrosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andreas Kammerlander, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405987
- Sponsor's protocol ID
- T1-strain-2436
- Status last verified
- Mar 2020
- First submitted
- 14 Jan 2018
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of T1-mapping and LV Strain Analysis by CMR
- ClinicalTrials.gov ID
- NCT03405987
- Acronym / sponsor ID
- T1-strain-2436
- Conditions
- Myocardial Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECV < median | – | Diagnostic Test: Strain analysis by CMR |
| ECV ≥ median | – | Diagnostic Test: Strain analysis by CMR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- undergoing CMR
- willingness to participate
Key exclusion criteria (2 listed)
- <18 years old
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strain analysis by CMRStrain analysis by CMR will be performed | Diagnostic test | ECV < median, ECV ≥ median |
Primary outcome
Association of native LV T1-values and strain analysis
Time frame: Baseline
Association of native LV T1-values and strain analysis by CMR
Association of ECV and strain analysis
Time frame: Baseline
Association of ECV and strain analysis by CMR
Association of strain analysis and outcome
Time frame: 2 years
Association of strain analysis by CMR and outcome (combination of cardiovascular hospitalization or death)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Fibrosis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Kammerlander, MD (014040046140, andreas.kammerlander@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of native LV T1-values and strain analysis (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.