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

NCT05597657 | Completed

• 1 other identifier: H-21025256
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Magnetic Resonance; T1 Mapping; Healthy Individuals

Outcome Measures

Primary Outcomes (3)

• 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

• Change of T1 values (substudy 2)

  Change in T1 values after fluid administration

  Through study completion, an average of 1 year

• 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

Study Arms (1)

Fluid administration (substudy 2)

OTHER

Other: Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)

Interventions

Fluid administration (Fresenius Kabi Sodium Chloride 0.9%) 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.

Fluid administration (substudy 2)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-89 years
• Healthy

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Study Officials

• Katrine A Myhr, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principital Investigator

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: October 28, 2022
• Study Start: October 12, 2021
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: From study end
• Access Criteria: Researchers who provide a methodological sound proposal

Locations

DK (1)