Cardiac Magnetic ResonanceNATIVENCT05597657
Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals
A study testing Fluid administration (Fresenius Kabi Sodium Chloride 0.9%) in people with Cardiac Magnetic Resonance and T1 Mapping, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study is to determine the normal variation of T1 values with cardiac magnetic resonance in healthy individuals with respect to reproducibility, changes over time, and dependency on hydration status. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Magnetic Resonance, T1 Mapping, Healthy Individuals
- What is being tested?
- Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Oct 2021to 15 Sep 2023
- Phase
- Interventional
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-89 years
- Healthy
Who cannot join
- Chronic disease (e.g. cardiovascular disease, rheumatological disease, lung disease)
- Medications affecting the cardiovascular system (e.g. antihypertensives, statins, anticoagulants)
- Contraindications for CMR (claustrophobia, pregnancy, magnetic metallic implants)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine the normal variation of T1 values with cardiac magnetic resonance in healthy individuals with respect to reproducibility, changes over time, and dependency on hydration status.
Read the detailed description
T1 mapping with cardiac magnetic resonance (CMR) is a novel non-invasive technique to quantitatively characterize the myocardium. T1 mapping is a surrogate marker of myocardial edema and fibrosis, and has the potential to be implemented in the diagnosis and follow-up of various cardiac diseases. However, there is limited data on the natural variation of T1 mapping in healthy individuals.
The study comprises three substudies:
- Reproducibility: Two identical CMR examinations with T1 mapping will be performed on the same day .
- Hydration changes: Participants will receive two liters of isotonic saline intravenously between two identical CMR with T1 mapping and echocardiographic examinations. The post-fluid order of CMR and echocardiography will be randomized.
- Time changes: Participants will undergo CMR with T1 mapping at baseline, at 6-months follow-up, and at 1-year follow-up.
- Conditions
- Cardiac Magnetic Resonance, T1 Mapping, Healthy Individuals
- Being tested
- Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)Other
All participants in substudy 2 will be administered 2 liters of isotonic saline infusion (Fresenius Kabi Sodium Chloride 0.9%) intravenously. CMR and echocardiography will be performed before and after infusion.
| Study group | Role | What they receive |
|---|---|---|
| Fluid administration (substudy 2) | Other | Not described Receives: Other: Fluid administration (Fresenius Kabi Sodium Chloride 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in T1 values (substudy 1)
Change in T1 values between two consecutive scans on the same day
Measured: Through study completion, an average of 1 year
Change of T1 values (substudy 2)
Change in T1 values after fluid administration
Measured: Through study completion, an average of 1 year
Change in T1 values (substudy 3)
Change in T1 values over time (baseline, 6 months, 1 year)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start12 Oct 2021
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Magnetic ResonanceStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cardiovascular Academy (DCA), Eva og Henry Frænkels Mindefond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
- Responsible party
- Principal investigator, Katrine Aagaard Myhr, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Katrine A Myhr, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597657
- Sponsor's protocol ID
- H-21025256
- Acronym
- NATIVE
- Status last verified
- Nov 2023
- First submitted
- 25 May 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05597657
- Acronym / sponsor ID
- NATIVE / H-21025256
- Conditions
- Cardiac Magnetic Resonance, T1 Mapping, Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cardiovascular Academy (DCA), Eva og Henry Frænkels Mindefond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 28 Oct 2022 (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 purpose of the study is to determine the normal variation of T1 values with cardiac magnetic resonance in healthy individuals with respect to reproducibility, changes over time, and dependency on hydration status.
Detailed description
T1 mapping with cardiac magnetic resonance (CMR) is a novel non-invasive technique to quantitatively characterize the myocardium. T1 mapping is a surrogate marker of myocardial edema and fibrosis, and has the potential to be implemented in the diagnosis and follow-up of various cardiac diseases. However, there is limited data on the natural variation of T1 mapping in healthy individuals.
The study comprises three substudies:
- Reproducibility: Two identical CMR examinations with T1 mapping will be performed on the same day .
- Hydration changes: Participants will receive two liters of isotonic saline intravenously between two identical CMR with T1 mapping and echocardiographic examinations. The post-fluid order of CMR and echocardiography will be randomized.
- Time changes: Participants will undergo CMR with T1 mapping at baseline, at 6-months follow-up, and at 1-year follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid administration (substudy 2) | Other | Other: Fluid administration (Fresenius Kabi Sodium Chloride 0.9%) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-89 years
- Healthy
Key exclusion criteria (3 listed)
- Chronic disease (e.g. cardiovascular disease, rheumatological disease, lung disease)
- Medications affecting the cardiovascular system (e.g. antihypertensives, statins, anticoagulants)
- Contraindications for CMR (claustrophobia, pregnancy, magnetic metallic implants)
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 |
|---|---|---|
| Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)All participants in substudy 2 will be administered 2 liters of isotonic saline infusion (Fresenius Kabi Sodium Chloride 0.9%) intravenously. CMR and echocardiography will be performed before and after infusion. | Other | Fluid administration (substudy 2) |
Primary outcome
Change in T1 values (substudy 1)
Time frame: Through study completion, an average of 1 year
Change in T1 values between two consecutive scans on the same day
Change of T1 values (substudy 2)
Time frame: Through study completion, an average of 1 year
Change in T1 values after fluid administration
Change in T1 values (substudy 3)
Time frame: Through study completion, an average of 1 year
Change in T1 values over time (baseline, 6 months, 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Data can be provided upon request
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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.
Katrine A Myhr, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid administration (Fresenius Kabi Sodium Chloride 0.9%) in people with Cardiac Magnetic Resonance and T1 Mapping, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 18 Nov 2023. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in T1 values (substudy 1) (time frame: Through study completion, an average of 1 year). 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 18 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.