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

November 15, 2023 updated by: Katrine Aagaard Myhr, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year
Change of T1 values (substudy 2)
Time Frame: Through study completion, an average of 1 year
Change in T1 values after fluid administration
Through study completion, an average of 1 year
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)
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • H-21025256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data can be provided upon request

IPD Sharing Time Frame

From study end

IPD Sharing Access Criteria

Researchers who provide a methodological sound proposal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Magnetic Resonance

Clinical Trials on Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe