Translational Research GRICS-CineCardiac | NCT06878768

Studies
Translational Research GRICS-CineCardiac

NCT06878768

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Status

Completed

Last Update Posted

Apr 23, 2026Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Ischemic Cardiopathy
Dilated Cardiomyopathy

Interventions

Additional free breathing MR acquisitions

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-A00789-30	Registry Identifier	IDRCB

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Feb 21, 2013

First Submission Date that Met QC Criteria

Mar 10, 2025

First Posted Date

Mar 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Patients	Experimental		Device: Additional free breathing MR acquisitions

Name	Type	Description	Arm Group Labels	Other Names
Additional free breathing MR acquisitions	Device		Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Right ventricular end-diastolic volume	Free-breathing and breath-hold measurements	Day 1
Left ventricular end-diastolic volume	Free-breathing and breath-hold measurements

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Brabois		Vandœuvre-lès-Nancy		54511	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002311	Cardiomyopathy, Dilated

Ancestor Terms

ID	Term
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009202	Cardiomyopathies

Browse Leaves

Not provided

Browse Branches

Not provided