Heart Map Study -Determination of Myocardial Relaxation Times Values in Healthy Volunters (HeartMS)
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|ClinicalTrials.gov Identifier: NCT01712581|
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : September 8, 2014
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|
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 (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|
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|
- 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 ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01712581
|Rouen University Hospital|
|Rouen, France, 76031|