Measurements of Myocardial Relaxation Time by MRI During Respiration

Heart Transplantation Clinical Trial

— ARTEMIS  

Official title:

Measurements of Myocardial Relaxation Time by MRI During Respiration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234205
• Other study ID #: 2011-A00154-37
• Status: Completed
• Phase: N/A
• First received: July 26, 2017
• Last updated: August 2, 2017
• Start date: August 31, 2011
• Est. completion date: December 19, 2012

Study information

• Verified date: July 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 19, 2012
• Est. primary completion date: December 19, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Nancy Brabois	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality assessed y senior radiologists		baseline
Primary	Movement correction in images assessed by senior radiologists		baseline
Secondary	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