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

Not Applicable

Completed

• Conditions: Healthy Individuals; Cardiac Magnetic Resonance; T1 Mapping
• Interventions: Other: Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)

• Registration Number: NCT05597657
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2021-10-12
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-28
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluid administration (substudy 2)	Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)	-

Primary Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark