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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.
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.
Age
18 - 89 years
Sex
ALL
Healthy Volunteers
Yes
Rigshospitalet
Copenhagen, Denmark
Start Date
October 12, 2021
Primary Completion Date
September 15, 2023
Completion Date
September 15, 2023
Last Updated
November 18, 2023
37
ACTUAL participants
Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)
OTHER
Lead Sponsor
Rigshospitalet, Denmark
Collaborators
NCT07382128
NCT07287306
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07047300