Measurements of Myocardial Relaxation Time by MRI During Respiration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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MRI scan during free respiration

Group Type EXPERIMENTAL

MRI scan

Intervention Type 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

Interventions

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MRI scan

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

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No