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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712581
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : September 8, 2014
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Normal Myocardial T1, T2 and T2* Values Other: Magnetic Resonance Imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determination of Myocardial Relaxation Times Values in Healthy Volunters
Study Start Date : August 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712581

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Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen

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Responsible Party: University Hospital, Rouen Identifier: NCT01712581     History of Changes
Other Study ID Numbers: 2012/071/HP
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Keywords provided by University Hospital, Rouen:
normal myocardial T1, T2 and T2* values