Measurements of Myocardial Relaxation Time by MRI During Respiration (ARTEMIS)

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.

Study Overview

• Status: Completed
• Conditions: Heart Transplantation
• Intervention / Treatment: Device: MRI scan

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les nancy, France
    • CHRU de Nancy Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI scan during free respiration	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Image quality assessed y senior radiologists	baseline
Movement correction in images assessed by senior radiologists	baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2011
• Primary Completion (Actual): December 19, 2012
• Study Completion (Actual): December 19, 2012

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2011-A00154-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No