Measurements of Myocardial Relaxation Time by MRI During Respiration

Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. This technique needs successively around ten FSE sequences during apnea. Weak reproducibility of successive apneas and discomfort of patient limit the precision of this measurement and consequently its use in standard care. The ARTEMIS study method allows the examination during free respiration without prolonging the duration of examination compared to the examination during apnea. Moreover, image processing is simplified and correction of respiratory movements renders results more reliable.

This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows to obtain diagnostic images without movement artifacts.

The primary objective si to show the feasibility of ARTEMIS method for measurement of myocardial T2 relaxation time during free respiration in cardiac transplant patients.

The secondary objective is to collect quantitative data to compare ARTEMIS method of measurement of T2 during free respiration and standard clinical practice during apnea.

Completed

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Key information

Conditions

Heart Transplantation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy Brabois

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To have had a heart transplant, whenever
To have an MRI scan of heart with measurement of T2 relaxation time (whatever the reason for examination)
Major
To be aware and cooperative
Affiliation to social security plan
To have given written consent after having received oral and written, clear and intelligible information

Exclusion criteria

All contraindications to MRI (implantable defibrillator, cochlear implant, neurosurgical clip, intraorbital or encephalic metallic foreign body, endoprosthesis installed since less than 4 weeks, osteosynthesis materials installed since less than 6 weeks…)
Instable hemodynamic status, acute respiratory failure, uncertain general status or necessity of continuous monitoring incompatible with MRI examination
Minors or being under juridical protection or absence of social security
Refusal or impossibility of informed consent of patient

Treatment and study plan

MRI scan

Device

MRI standard protocol with addition of:

a second clinical respiratory belt besides belt usually installed for clinical examination
a second clinical electrocardiogram sensor besides sensor usually installed for clinical examination
12 sequences during free respiration are added lasting supplementary 15 minutes
Use of cardiac antennae usually used for cardiac MRI scans

Primary outcomes

Image quality assessed y senior radiologists

Time frame: baseline
Movement correction in images assessed by senior radiologists

Time frame: baseline

Secondary outcomes

Quantitative measurement of myocardial transversal relaxation time in 6 segments of short median axe cross-section of left ventricle in standard and ARTEMIS images

Time frame: baseline

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: ARTEMIS

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jul 31, 2017
Registry last updated: Aug 3, 2017

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed