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Completed

NCT Number: NCT05597657

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

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.

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Key information

Conditions

Cardiac Magnetic Resonance Healthy Individuals T1 Mapping

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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:

  • Reproducibility: Two identical CMR examinations with T1 mapping will be performed on the same day .
  • 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.
  • Time changes: Participants will undergo CMR with T1 mapping at baseline, at 6-months follow-up, and at 1-year follow-up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change in T1 values (substudy 1)

    Time frame: 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)

    Time frame: Through study completion, an average of 1 year

    Change in T1 values after fluid administration

  3. Change in T1 values (substudy 3)

    Time frame: Through study completion, an average of 1 year

    Change in T1 values over time (baseline, 6 months, 1 year)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

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

Registry information

Acronym: NATIVE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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