Ischemic CardiopathyNCT06878768
Translational Research GRICS-CineCardiac
A study testing Additional free breathing MR acquisitions in people with Ischemic Cardiopathy and Dilated Cardiomyopathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiopathy, Dilated Cardiomyopathy
- What is being tested?
- Additional free breathing MR acquisitions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidate to cardiac MR exam because of ischemic or dilated cardiopathy
- legally an adult
- having heath insurance
- having signed the consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ischemic Cardiopathy, Dilated Cardiomyopathy
- Being tested
- Additional free breathing MR acquisitions
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional free breathing MR acquisitionsDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Device: Additional free breathing MR acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative image reading by the radiologist
Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire
Measured: 1 Month
Quantitative image analysis by the radiologist
Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire
Measured: 1 Month
Secondary outcomes (11)
Right ventricular end-diastolic volume
Free-breathing and breath-hold measurements
Measured: Day 1
Left ventricular end-diastolic volume
Free-breathing and breath-hold measurements
Measured: Day 1
Right ventricular end-systolic volume
Free-breathing and breath-hold measurements
Measured: Day 1
Left ventricular end-systolic volume
Free-breathing and breath-hold measurements
Measured: Day 1
Right ventricular systolic ejection volume
Free-breathing and breath-hold measurements
Measured: Day 1
Left ventricular systolic ejection volume
Free-breathing and breath-hold measurements
Measured: Day 1
Right ventricular ejection fractions
Free-breathing and breath-hold measurements
Measured: Day 1
Left ventricular ejection fractions
Free-breathing and breath-hold measurements
Measured: Day 1
Left ventricular mass in diastole
Free-breathing and breath-hold measurements
Measured: Day 1
Aortic flow
Free-breathing and breath-hold measurements
Measured: Day 1
Analysis of the segmental kinetics of the left ventricle
Free-breathing and breath-hold measurements
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiopathyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878768
- Sponsor's protocol ID
- C10-04
- Other IDs
- 2010-A00789-30
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2013
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagerie Cardiaque Ciné Par résonance magnétique en Respiration Libre
- ClinicalTrials.gov ID
- NCT06878768
- Acronym / sponsor ID
- C10-04
- Conditions
- Ischemic Cardiopathy, Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Additional free breathing MR acquisitions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- candidate to cardiac MR exam because of ischemic or dilated cardiopathy
- legally an adult
- having heath insurance
- having signed the consent form
Key exclusion criteria (6 listed)
- dyspnea
- atrial fibrillation
- pain while lying on the back for a long time
- inability to follow a procedure
- contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional free breathing MR acquisitions | Device | Patients |
Primary outcome
Qualitative image reading by the radiologist
Time frame: 1 Month
Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire
Quantitative image analysis by the radiologist
Time frame: 1 Month
Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire
11 secondary outcomes
Right ventricular end-diastolic volume
Time frame: Day 1
Left ventricular end-diastolic volume
Time frame: Day 1
Right ventricular end-systolic volume
Time frame: Day 1
Left ventricular end-systolic volume
Time frame: Day 1
Right ventricular systolic ejection volume
Time frame: Day 1
Left ventricular systolic ejection volume
Time frame: Day 1
Right ventricular ejection fractions
Time frame: Day 1
Left ventricular ejection fractions
Time frame: Day 1
Left ventricular mass in diastole
Time frame: Day 1
Aortic flow
Time frame: Day 1
Analysis of the segmental kinetics of the left ventricle
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional free breathing MR acquisitions in people with Ischemic Cardiopathy and Dilated Cardiomyopathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative image reading by the radiologist (time frame: 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.