Cardiac Magnetic Resonance, Healthy Individuals, T1 Mapping
Conditions
Brief 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.
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: 1. Reproducibility: Two identical CMR examinations with T1 mapping will be performed on the same day . 2. 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. 3. Time changes: Participants will undergo CMR with T1 mapping at baseline, at 6-months follow-up, and at 1-year follow-up.
Interventions
OTHERFluid 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.
Sponsors
Danish Cardiovascular Academy (DCA)
Eva og Henry Frænkels Mindefond
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-89 years * Healthy
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in T1 values (substudy 1) | 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) | Through study completion, an average of 1 year | Change in T1 values after fluid administration |
| Change in T1 values (substudy 3) | Through study completion, an average of 1 year | Change in T1 values over time (baseline, 6 months, 1 year) |
Countries
Denmark
Outcome results
None listed