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

NCT ID: NCT01712581

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-02-28

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.

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.

Conditions

Normal Myocardial T1, T2 and T2* Values

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: OTHER

Interventions

Magnetic Resonance Imaging

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2012/071/HP

Identifier Type: -

Identifier Source: org_study_id