Measurements of Myocardial Relaxation Time by MRI During Respiration

NCT03234205 | Completed

• 1 other identifier: 2011-A00154-37
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (2)

• Image quality assessed y senior radiologists

  baseline

• Movement correction in images assessed by senior radiologists

  baseline

Secondary Outcomes (1)

• 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

Study Arms (1)

MRI scan during free respiration

EXPERIMENTAL

Device: MRI scan

Interventions

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

MRI scan during free respiration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy Brabois

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 31, 2017
• Study Start: August 31, 2011
• Primary Completion: December 19, 2012
• Study Completion: December 19, 2012
• Last Updated: August 3, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)