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

Healthy Individuals Clinical Trial

— NATIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597657
• Other study ID #: H-21025256
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: September 15, 2023

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Magnetic Resonance
• Healthy Individuals

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Cardiovascular Academy (DCA), Eva og Henry Frænkels Mindefond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change of T1 values (substudy 2)	Change in T1 values after fluid administration	Through study completion, an average of 1 year
Primary	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