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

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Rouen
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01712581
First received: October 17, 2012
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Normal Myocardial T1, T2 and T2* Values
 Other: Magnetic Resonance Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Determination of Myocardial Relaxation Times Values in Healthy Volunters

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712581

Locations
France
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: sarah NEFOUSSI, MD     0332886496     sarah.nefoussi@chu-rouen.fr    
Principal Investigator: sarah NEFOUSSI, MD            
Sub-Investigator: jerome CAUDRON, MD            
Sub-Investigator: Jean Nicolas DACHER, MD PhD            
Sponsors and Collaborators
University Hospital, Rouen
Novartis
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01712581     History of Changes
Other Study ID Numbers: 2012/071/HP
Study First Received: October 17, 2012
Last Updated: October 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
normal myocardial T1, T2 and T2* values

ClinicalTrials.gov processed this record on May 16, 2013