- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06878768
Translational Research GRICS-CineCardiac
Imagerie Cardiaque Ciné Par résonance magnétique en Respiration Libre
This project is a pilot study which aims at showing the feasibility of free breathing cardiac MRI using GRICS (Generalized Reconstruction by Inversion of Coupled System)software in a clinical environment.
The GRICS technique has been developed by the IADI (Diagnostic, Adaptive and Interventional Imaging)lab, Nancy, France. It enables free breathing MRI thanks to a reconstruction algorithm which provides artefact-free images based on raw MR data and physiological data from external sensors (respiratory belts, ECG.
In this study, we want to acquire free breathing cardiac cine images during a standard cardiac MR exam and compare those data with the breath-hold ones.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vandœuvre-lès-Nancy, France, 54511
- CHU Brabois
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- candidate to cardiac MR exam because of ischemic or dilated cardiopathy
- legally an adult
- having heath insurance
- having signed the consent form
Exclusion Criteria:
- dyspnea
- atrial fibrillation
- pain while lying on the back for a long time
- inability to follow a procedure
- contraindication to MRI
- contraindication to gadolinium chelate injection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative image reading by the radiologist
Time Frame: 1 Month
|
Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire
|
1 Month
|
|
Quantitative image analysis by the radiologist
Time Frame: 1 Month
|
Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire
|
1 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Right ventricular end-diastolic volume
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Left ventricular end-diastolic volume
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Right ventricular end-systolic volume
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Left ventricular end-systolic volume
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Right ventricular systolic ejection volume
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Left ventricular systolic ejection volume
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Right ventricular ejection fractions
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Left ventricular ejection fractions
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Left ventricular mass in diastole
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Aortic flow
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
|
Analysis of the segmental kinetics of the left ventricle
Time Frame: Day 1
|
Free-breathing and breath-hold measurements
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C10-04
- 2010-A00789-30 (Registry Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.