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Trial record 14 of 181 for:    DCLRE1C

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

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ClinicalTrials.gov Identifier: NCT03234205
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Heart Transplantation Device: MRI scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Measurements of Myocardial Relaxation Time by MRI During Respiration
Actual Study Start Date : August 31, 2011
Actual Primary Completion Date : December 19, 2012
Actual Study Completion Date : December 19, 2012

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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




Primary Outcome Measures :
  1. Image quality assessed y senior radiologists [ Time Frame: baseline ]
  2. Movement correction in images assessed by senior radiologists [ Time Frame: baseline ]

Secondary Outcome Measures :
  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 [ Time Frame: baseline ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234205


Locations
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France
CHRU de Nancy Brabois
Vandoeuvre les nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03234205     History of Changes
Other Study ID Numbers: 2011-A00154-37
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No