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

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05597657
• Collaborator: Danish Cardiovascular Academy (DCA) (Other), Eva og Henry Frænkels Mindefond (Other), Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19.6
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Magnetic Resonance; T1 Mapping; Healthy Individuals	Other: Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals
• Actual Study Start Date: Oct 12, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Fluid administration (substudy 2)	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.

Outcome Measures

Primary Outcome Measures

1. 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

2. Change of T1 values (substudy 2) [Through study completion, an average of 1 year]

   Change in T1 values after fluid administration

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Katrine A Myhr, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katrine Aagaard Myhr, Principital Investigator, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT05597657
• Other Study ID Numbers: H-21025256
• First Posted: Oct 28, 2022
• Last Update Posted: Oct 28, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 28, 2022