Clinical trial NCT03234205: Measurements of Myocardial Relaxation Time by MRI During Respiration
Official title: Measurements of Myocardial Relaxation Time by MRI During Respiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplantation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Image quality assessed y senior radiologists
timeFrame: baseline
measure: Movement correction in images assessed by senior radiologists
timeFrame: baseline
Secondary outcomes:
measure: Quantitative measurement of myocardial transversal relaxation time in 6 segments of short median axe cross-section of left ventricle in standard and ARTEMIS images
timeFrame: baseline
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: CHRU de Nancy Brabois
Study officials:
References: