NCT06878768

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
12.1 years until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
Last Updated

April 23, 2026

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

February 21, 2013

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Qualitative image reading by the radiologist

    Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire

    1 Month

  • Quantitative image analysis by the radiologist

    Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire

    1 Month

Secondary Outcomes (11)

  • Right ventricular end-diastolic volume

    Day 1

  • Left ventricular end-diastolic volume

    Day 1

  • Right ventricular end-systolic volume

    Day 1

  • Left ventricular end-systolic volume

    Day 1

  • Right ventricular systolic ejection volume

    Day 1

  • +6 more secondary outcomes

Study Arms (1)

Patients

EXPERIMENTAL
Device: Additional free breathing MR acquisitions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • candidate to cardiac MR exam because of ischemic or dilated cardiopathy
  • legally an adult
  • having heath insurance
  • having signed the consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

March 17, 2025

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 23, 2026

Record last verified: 2025-03

Locations