Heart DiseasesBCM-CMR-T1NCT03372512
Fluid Status and T1-mapping by CMR
An observational study of Heart Diseases and Heart Failure, run by Medical University of Vienna at 1 site in Austria.
Trial summary
It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging. In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases, Heart Failure, Valvular Heart Disease
- What is being tested?
- Bioimpedance spectroscopy
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 8 May 2018to 15 Dec 2020
- How long will I take part?
- 3 Years
- 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 cardiovascular magnetic resonance imaging including T1-mapping are invited to participate in the study where fluid status will be assessed by bioimpedance spectroscopy right before cardiovascular magnetic resonance imaging.
Who may be able to join
- written informed consent
- patient undergoing cardiovascular magnetic resonance imaging
Who cannot join
- Unwillingness to participate
- 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
Official title: Fluid Status Assessed by Bioelectrical Impedance Spectroscopy and Its Association With T1-mapping by Cardiovascular Magnetic Resonance Imaging
It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging.
In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.
- Conditions
- Heart Diseases, Heart Failure, Valvular Heart Disease
- Being tested
- Bioimpedance spectroscopy
- Medical subject headings
- Heart Diseases, Heart Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance spectroscopyDiagnostic test
Also called BCM measurement
Fluid overload will be assessed by bioimpedance spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Fluid overload (Liters) ≥ median | Not described Receives: Diagnostic Test: Bioimpedance spectroscopy | |
| Fluid overload (Liters) < median | Not described Receives: Diagnostic Test: Bioimpedance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Native T1-mapping
Association of fluid overload and native T1 values of left ventricular myocardium
Measured: baseline
Extracellular Volume by Cardiovascular magnetic resonance imaging
Association of fluid overload and extracellular volume of left ventricular myocardium
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start8 May 2018
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- 200 participants (estimated)
- Target duration
- 3 Years
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
- NCT03372512
- Sponsor's protocol ID
- BCM-CMR-T1
- Acronym
- BCM-CMR-T1
- Status last verified
- Aug 2019
- First submitted
- 7 Dec 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Status Assessed by Bioelectrical Impedance Spectroscopy and Its Association With T1-mapping by Cardiovascular Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03372512
- Acronym / sponsor ID
- BCM-CMR-T1 / BCM-CMR-T1
- Conditions
- Heart Diseases, Heart Failure, Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 13 Dec 2017 (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.
It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging.
In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid overload (Liters) ≥ median | – | Diagnostic Test: Bioimpedance spectroscopy |
| Fluid overload (Liters) < median | – | Diagnostic Test: Bioimpedance spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiovascular magnetic resonance imaging including T1-mapping are invited to participate in the study where fluid status will be assessed by bioimpedance spectroscopy right before cardiovascular magnetic resonance imaging.
Key inclusion criteria (2 listed)
- written informed consent
- patient undergoing cardiovascular magnetic resonance imaging
Key exclusion criteria (2 listed)
- Unwillingness to participate
- 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 |
|---|---|---|
| Bioimpedance spectroscopyAlso: BCM measurementFluid overload will be assessed by bioimpedance spectroscopy | Diagnostic test | Fluid overload (Liters) < median, Fluid overload (Liters) ≥ median |
Primary outcome
Native T1-mapping
Time frame: baseline
Association of fluid overload and native T1 values of left ventricular myocardium
Extracellular Volume by Cardiovascular magnetic resonance imaging
Time frame: baseline
Association of fluid overload and extracellular volume of left ventricular myocardium
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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 Heart Diseases and Heart Failure, 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 14 Aug 2019. 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 PhD (004314040046140, 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?
Native T1-mapping (time frame: baseline). The study lists 2 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 14 Aug 2019.