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

NCT ID: NCT05597657

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2023-09-15

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.

Conditions

Cardiac Magnetic Resonance; T1 Mapping; Healthy Individuals

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fluid administration (substudy 2)

Group Type: OTHER

Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danish Cardiovascular Academy (DCA)

UNKNOWN

Sponsor Role: collaborator

Eva og Henry Frænkels Mindefond

OTHER

Sponsor Role: collaborator

Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Katrine Aagaard Myhr

Principital Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katrine A Myhr, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-21025256

Identifier Type: -

Identifier Source: org_study_id