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Measurements of Myocardial Relaxation Time by MRI During Respiration

Measurements of Myocardial Relaxation Time by MRI During Respiration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03234205
Acronym
ARTEMIS
Enrollment
9
Registered
2017-07-31
Start date
2011-08-31
Completion date
2012-12-19
Last updated
2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

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.

Interventions

DEVICEMRI 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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Image quality assessed y senior radiologistsbaseline
Movement correction in images assessed by senior radiologistsbaseline

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026