Heart Map Study -Determination of Myocardial Relaxation Times Values in Healthy Volunters (HeartMS)

April 13, 2026 updated by: University Hospital, Rouen

Determination of Myocardial Relaxation Times Values in Healthy Volunters

T1, T2 and T2* relaxation times, as determined with cardiac MRI, are markers of myocardial tissue content (water, fibrosis, iron).

The aim of study is to determine the normal values of T1, T2 and T2* relaxation times in healthy volunters aged 18-69 years using 1.5T clinical MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiac MRI is more and more used in patients with ischaemic and non-ischaemic heart diseases. One major strength of MRI is its great potential for tissue characterization.

For early detection and follow-up of patients with hemosiderosis, who are at high risk of myocardial iron overload, cardiac MRI seems to be the most reliable, more reproducible and less invasive method. In addition MRI does not require injection of contrast media. It is commonly accepted that myocardial T2 * value of less than 20 ms corresponds to iron overload in the myocardium. However, this value is based on a small sample study and nomogram based on age were not published. The determination of normal values in a population of healthy controls according to age appears to be a prerequisite for reliable interpretation of imaging data.

Moreover, myocardial edema and fibrosis are more and more evaluated with cardiac MRI using T1 and T2 myocardial relaxation times. As for T2* values, normogram of T1 and T2 values based on age were not published.

The increasing use of T1, T2 and T2* mapping sequences in clinical practice for tissue characterization of the myocardium justify the implementation of a study in healthy volunteers to determine normograms based on age.

Study Type

Interventional

Enrollment (Actual)

175

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

  • France
      • Rouen, France, 76031
        • Rouen University Hospital

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 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteers over the age of 18 and less than 70
  • Volunteers able to understand and sign the consent and to give written informed consent
  • Female contraceptives if of childbearing age
  • Registered or entitled to social security system
  • Volunteers able to maintain supine for 20 minutes

Exclusion Criteria:

  • Major protected/under guardianship
  • Volunteers unable to maintain the supine position for 20 minutes
  • Claustrophobia
  • Volunteers with history of PRBC transfusion
  • Volunteers with history of hematologic disease or a disruption of iron status
  • Volunteers with history of cardiac disease including arrhythmias
  • Hypertension
  • Diabetes
  • Contra-indication for MRI: metal fragments in the eyes; implantable cardiac, neurological or ENT device; osteosynhesis material not compatible with MRI
  • Women who are pregnant or likely to be

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunters
175 Healthy volunters in the cohorte divided in 7 groups of age: 18-19 years old (ratio M/F: 1/1) 20-24 years old (ratio M/F: 1/1) 25-29 years old (ratio M/F: 1/1) 30-39 years old (ratio M/F: 1/1) 40-49 years old (ratio M/F: 1/1) 50-59 years old (ratio M/F: 1/1) 60-69 years old (ratio M/F: 1/1)
Other: Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The main objective is to determine normal T2 * values of the myocardium in a large adult population of healthy volunteers, using 1.5T cardiac MRI.
Time Frame: 24h
24h

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary objectives are to determine normal T1 and T2 values of the myocardium in a large adult population of healthy volunteers, using 1.5T cardiac MRI.
Time Frame: 24h
24h

Collaborators and Investigators

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

Sponsor

University Hospital, Rouen

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (Estimated)

October 23, 2012

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/071/HP

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.

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