Cardiac MRIIRM CardiaqueNCT05103852
Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.
A study testing Cardiac MRI in people with Cardiac MRI and Right Cardiac Catheterization, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac MRI, Right Cardiac Catheterization
- What is being tested?
- Cardiac MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2018to 22 Mar 2022
- 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
- Patient over 18 years old
- Having an indication for a diagnostic of right cardiac catheterization at the J Cartier Hospital for one of the following pathologies: dilated, restrictive cardiomyopathy, pulmonary arterial hypertension, chronic constrictive pericarditis, chronic post-embolic pulmonary heart.
- Subject affiliated or beneficiary of a social security scheme
- Patient having freely signed the informed consent.
Who cannot join
- Pregnancy (declarative, known pregnancy, any unexplained period delay in a woman of childbearing age)
- Presence of a contraindication to MRI: intraocular metallic splinter, surgical clip for cerebral aneurysm, claustrophobia, defibrillator, implanted electronic equipment) or to gadolinium chelates (anaphylactic reactions to gadolinium chelates, creatinine clearance <= 30 ml / min).
- Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
- Patient participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation.
- Conditions
- Cardiac MRI, Right Cardiac Catheterization
- Being tested
- Cardiac MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIProcedure or surgery
vigilant patient installed in the MRI with compatible ECG electrodes for synchronization and monitoring, blood pressure cuff for monitoring, cardiac antenna. Sterile drape over the femoral region, femoral local anesthesia, femoral venipuncture, Swan Ganz probe venous navigation (CE marking, MRI compatible at 1.5T) with balloon inflated with 2 cc of gadolinium, navigation under real time SSFP cine sequence.
| Study group | Role | What they receive |
|---|---|---|
| Patients with right cardiac catheterization | Experimental | Not described Receives: Procedure: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation
Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation, as well as all the anatomical, functional, flow and substrate determination data by magnetic resonance (N / 35,%).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start13 Dec 2018
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac MRIStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103852
- Sponsor's protocol ID
- 2017-A03145-48
- Acronym
- IRM Cardiaque
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.
- ClinicalTrials.gov ID
- NCT05103852
- Acronym / sponsor ID
- IRM Cardiaque / 2017-A03145-48
- Conditions
- Cardiac MRI, Right Cardiac Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 2 Nov 2021 (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.
The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with right cardiac catheterization | Experimental | Procedure: Cardiac MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Having an indication for a diagnostic of right cardiac catheterization at the J Cartier Hospital for one of the following pathologies: dilated, restrictive cardiomyopathy, pulmonary arterial hypertension, chronic constrictive pericarditis, chronic post-embolic pulmonary heart.
- Subject affiliated or beneficiary of a social security scheme
- Patient having freely signed the informed consent.
Key exclusion criteria (4 listed)
- Pregnancy (declarative, known pregnancy, any unexplained period delay in a woman of childbearing age)
- Presence of a contraindication to MRI: intraocular metallic splinter, surgical clip for cerebral aneurysm, claustrophobia, defibrillator, implanted electronic equipment) or to gadolinium chelates (anaphylactic reactions to gadolinium chelates, creatinine clearance <= 30 ml / min).
- Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
- Patient participating in another clinical study
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 |
|---|---|---|
| Cardiac MRIvigilant patient installed in the MRI with compatible ECG electrodes for synchronization and monitoring, blood pressure cuff for monitoring, cardiac antenna. Sterile drape over the femoral region, femoral local anesthesia, femoral venipuncture, Swan Ganz probe venous navigation (CE marking, MRI compatible at 1.5T) with balloon inflated with 2 cc of gadolinium, navigation under real time SSFP cine sequence. | Procedure or surgery | Patients with right cardiac catheterization |
Primary outcome
Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation
Time frame: 24 hours
Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation, as well as all the anatomical, functional, flow and substrate determination data by magnetic resonance (N / 35,%).
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 16 Jul 2026.
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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 Cardiac MRI in people with Cardiac MRI and Right Cardiac Catheterization, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 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 16 Jul 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?
Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation (time frame: 24 hours). 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 16 Jul 2026.