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

NCT01712581 | Completed DMC

• 1 other identifier: 2012/071/HP
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Myocardial T1, T2 and T2* Values

Keywords

normal myocardial T1, T2 and T2* values

Outcome Measures

Primary Outcomes (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.

  24h

Secondary Outcomes (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.

  24h

Study Arms (1)

Healthy volunters

EXPERIMENTAL

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

Interventions

Magnetic Resonance Imaging OTHER

Healthy volunters

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Novartis: collaborator

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (1)

• Cadour F, Caudron J, Gillibert A, Normant S, Dacher JN. Normal variations of myocardial T1, T2 and T2* values at 1.5 T cardiac MRI in sex-matched healthy volunteers. Diagn Interv Imaging. 2025 Jun;106(6):217-225. doi: 10.1016/j.diii.2025.01.005. Epub 2025 Jan 26.

  PMID: 39864993 RESULT

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 23, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)