Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals

Study Overview
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Brief Summary
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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
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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.

Official Title
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Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals

Conditions
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Cardiac Magnetic Resonance, T1 Mapping, Healthy Individuals

Intervention / Treatment
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* Other: Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fluid administration (substudy 2)<br> | Other: Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in T1 values (substudy 1) | Change in T1 values between two consecutive scans on the same day | Through study completion, an average of 1 year | 
| Change of T1 values (substudy 2) | Change in T1 values after fluid administration | 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) | Through study completion, an average of 1 year |