Patients with Atrial Fibrillation and Healthy VoluntersMRI-HiRANCT06617624
Magnetic Resonance Imaging Development for High Resolution Atrial Structural and Functional Characterization
An observational study of Patients with Atrial Fibrillation and Healthy Volunters, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The main objective is to optimize the MRI protocol for the assessment of the LA in addition to a basic CMR protocol in order to define the best compromise between acquisition time and image quality (contrast between the different tissues, spatial and temporal resolutions, etc.) sufficient for accurate measurement of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients with Atrial Fibrillation and Healthy Volunters
- What is being tested?
- MRI and MRI Contrast
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3 groups of patients and 1 control group: paroxysmal AF (atrial fibrillation) (no AF during exam), persistent AF, permanent AF and healthy controls. 20 patients able to complete the full standard experimental examination corresponding to each AF group and 60 age/sex BMI class matched healthy volunteers, able to complete the full standard experimental examination.
Who may be able to join
- For all groups of AF patients:
- Over 18 years of age
- Participation to the MAESTRIA-AFNET 10 study
- Able to undergo an injected MRI examination
- Able to give consent
- Affiliated to French social security system
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- Specific inclusion criteria of AF patients (same as MAESTRIA-AFNET 10) Group 1: patients with paroxysmal AF (no AF during exam) clinically defined as AF episodes less than one week Group 2: patients with persistent AF, clinically defined as AF episodes longer than one week Group 3: patients with permanent AF, with no documented sinus rhythm or possibility to restore sinus rhythm by any means
- For healthy volunteers (Group 4):
- Over 18 years of age (including 30 subjects < 60 years)
- Able to undergo an MRI examination
- Able to give consent
- Affiliated to French social security system
Who cannot join
- For all groups
- Deprived of liberty or under legal protection (under guardianship or curatorship)
- Kidney disease with GFR <30 mL / min (because of the risks linked to the injection of DOTAREM ™ and iodine)
- Pregnant woman, breastfeeding, of childbearing age in the absence of effective contraception
- MRI contraindication (claustrophobia, patients with metallic foreign bodies)
- Participation to another interventional clinical trial (Jardé 1) For patients
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- Patients with a history of renal disease (renal transplant, single kidney, renal cancer)
- Patients who have received a dose of contrast in the last 24 hours
- Patients who had a previous allergic or anaphylactic reaction to gadolinium For volunteers
- Subjects with known cardiovascular pathology or under cardiovascular treatment
- Subjects with cardiovascular history
- Subjects with cardiac rhythm or conduction disorders
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The main objective is to optimize the MRI protocol for the assessment of the LA in addition to a basic CMR protocol in order to define the best compromise between acquisition time and image quality (contrast between the different tissues, spatial and temporal resolutions, etc.) sufficient for accurate measurement of morphological, structural and hemodynamic left atrial biomarkers.
Read the detailed description
This Magnetic Resonance imaging study of the heart aims to acquire images and measures of:
- Left atrial cine: compressed sensing cine imaging strategies will be tested for LA assessment by optimizing spatial and temporal resolution providing the best image quality relative to acceptable acquisition times. The whole heart should be covered during acquisition. Image quality and diagnosis of LA contraction preservation will be performed.
- Myocardial tissue characterization including:
- 3D isotropic ECG-gated with respiratory navigation late gadolinium enhancement (LGE) sequence for high resolution imaging of myocardial injury and fibrosis.
- High resolution free-breathing T1/T2 mapping to quantify myocardial water content and measure native T1 relaxation and extracellular volume. 2D free breathing LGE will complement the protocol.
- Cardiac adipose tissue imaging will be performed using gated Dixon imaging. Pericardial adipose tissue (PAT) will be measured covering the whole heart including groove epicardial adipose tissue (EAT).
- Flow measurements: test and optimize a 4D flow approach for the heart and aorta using compressed sensing and multi velocity encoding (VENC) encoding to insure high and precise multi-chamber velocity imaging(100, 150, 200, 250 cm/s). Two-chamber (including left appendage) in plane velocities will be compared between high resolution 2D and 4D. Of, note, such multi-VENC approach is mandatory for LA imaging because of the large heterogeneity of blood flow velocities within the LA during the cardiac cycle.
- Technology validation: comparison of cardiac triggering using the beat sensor vs. surface ECG-gating will be tested as a means of improving patient experience and speed up MRI acquisition for subsequent population imaging.
This task will be performed at the Cardiovascular MRI Imaging Platform and Core Lab at the Pitié-Salpêtrière Hospital site by SU-ICAN \& APHP (ICT), SU-LIB and SIEMENS partners with the goal to optimize, test and validate innovative approaches before wider application.
- Being tested
- MRI, MRI Contrast
- Keywords
- Atrial fibrillation, MRI, Acquisition optimisation, Biomarkers
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Healthy volunteer will have a non-injected cardiovascular MRI
MRI ContrastOther
Patients will have the gadolinium injected cardiovascular MRI
| Study group | Role | What they receive |
|---|---|---|
| Group 1: patient with paroxysmal AF (Atrial Fibrillation) (no AF during exam) | 20 patients able to complete the full standard experimental examination corresponding to paroxysmal AF group Receives: Other: MRI Contrast | |
| Group 2: patient with persistent AF (Atrial Fibrillation) | 20 patients able to complete the full standard experimental examination corresponding to persistent AF group Receives: Other: MRI Contrast | |
| Group 3: patient with permanent AF (Atrial Fibrillation) | 20 patients able to complete the full standard experimental examination corresponding to permanent AF group Receives: Other: MRI Contrast | |
| Group 4: healthy volunteer | 60 age/sex BMI class matched healthy volunteers, able to complete the full standard experimental examination. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of maximal Left Atrial (LA) longitudinal strain
Measurement of maximal Left Atrial (LA) longitudinal strain. Comparison between patients and healthy volunteers will allow to define normal values and thresholds for the given sequences.
Measured: 24 months
Secondary outcomes (6)
Various calibration settings against reference.
The metrics from the Linear regression and Bland and Altman analyses will be used to compare the various calibration settings against reference.
Measured: 24 months
The correlation coefficients from the linear regressions
The correlation coefficients from the linear regressions will be estimated to assess the associations mentioned in the secondary objectives between the new biomarkers and the more established biomarkers.
Measured: 24 months
The correlation coefficients from the linear regressions
The correlation coefficients from the linear regressions will be estimated to assess the associations mentioned in the secondary objectives between the new biomarkers and the more established biomarkers.Between LA imaging biomarkers and subcutaneous aging and pressure levels
Measured: 24 months
ROC analysis
Metric of ROC analysis
Measured: 24 months
The intra-operator coefficient of variation.
The intra-operator coefficient of variation.
Measured: 24 months
The inter-operator coefficient of variation.
The inter-operator coefficient of variation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients with Atrial Fibrillation and Healthy VoluntersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617624
- Sponsor's protocol ID
- APHP231076
- Other IDs
- 2023-A01951-44
- Acronym
- MRI-HiRA
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Development for High Resolution Atrial Structural and Functional Characterization
- ClinicalTrials.gov ID
- NCT06617624
- Acronym / sponsor ID
- MRI-HiRA / APHP231076
- Keywords
- Atrial fibrillation, MRI, Acquisition optimisation, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 27 Sep 2024 (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 main objective is to optimize the MRI protocol for the assessment of the LA in addition to a basic CMR protocol in order to define the best compromise between acquisition time and image quality (contrast between the different tissues, spatial and temporal resolutions, etc.) sufficient for accurate measurement of morphological, structural and hemodynamic left atrial biomarkers.
Detailed description
This Magnetic Resonance imaging study of the heart aims to acquire images and measures of:
- Left atrial cine: compressed sensing cine imaging strategies will be tested for LA assessment by optimizing spatial and temporal resolution providing the best image quality relative to acceptable acquisition times. The whole heart should be covered during acquisition. Image quality and diagnosis of LA contraction preservation will be performed.
- Myocardial tissue characterization including:
- 3D isotropic ECG-gated with respiratory navigation late gadolinium enhancement (LGE) sequence for high resolution imaging of myocardial injury and fibrosis.
- High resolution free-breathing T1/T2 mapping to quantify myocardial water content and measure native T1 relaxation and extracellular volume. 2D free breathing LGE will complement the protocol.
- Cardiac adipose tissue imaging will be performed using gated Dixon imaging. Pericardial adipose tissue (PAT) will be measured covering the whole heart including groove epicardial adipose tissue (EAT).
- Flow measurements: test and optimize a 4D flow approach for the heart and aorta using compressed sensing and multi velocity encoding (VENC) encoding to insure high and precise multi-chamber velocity imaging(100, 150, 200, 250 cm/s). Two-chamber (including left appendage) in plane velocities will be compared between high resolution 2D and 4D. Of, note, such multi-VENC approach is mandatory for LA imaging because of the large heterogeneity of blood flow velocities within the LA during the cardiac cycle.
- Technology validation: comparison of cardiac triggering using the beat sensor vs. surface ECG-gating will be tested as a means of improving patient experience and speed up MRI acquisition for subsequent population imaging.
This task will be performed at the Cardiovascular MRI Imaging Platform and Core Lab at the Pitié-Salpêtrière Hospital site by SU-ICAN \& APHP (ICT), SU-LIB and SIEMENS partners with the goal to optimize, test and validate innovative approaches before wider application.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: patient with paroxysmal AF (Atrial Fibrillation) (no AF during exam) | – | Other: MRI Contrast20 patients able to complete the full standard experimental examination corresponding to paroxysmal AF group |
| Group 2: patient with persistent AF (Atrial Fibrillation) | – | Other: MRI Contrast20 patients able to complete the full standard experimental examination corresponding to persistent AF group |
| Group 3: patient with permanent AF (Atrial Fibrillation) | – | Other: MRI Contrast20 patients able to complete the full standard experimental examination corresponding to permanent AF group |
| Group 4: healthy volunteer | – | Other: MRI60 age/sex BMI class matched healthy volunteers, able to complete the full standard experimental examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3 groups of patients and 1 control group: paroxysmal AF (atrial fibrillation) (no AF during exam), persistent AF, permanent AF and healthy controls. 20 patients able to complete the full standard experimental examination corresponding to each AF group and 60 age/sex BMI class matched healthy volunteers, able to complete the full standard experimental examination.
Key inclusion criteria (12 listed)
- Over 18 years of age
- Participation to the MAESTRIA-AFNET 10 study
- Able to undergo an injected MRI examination
- Able to give consent
- Affiliated to French social security system
Key exclusion criteria (12 listed)
- For all groups
- Deprived of liberty or under legal protection (under guardianship or curatorship)
- Kidney disease with GFR <30 mL / min (because of the risks linked to the injection of DOTAREM ™ and iodine)
- Pregnant woman, breastfeeding, of childbearing age in the absence of effective contraception
- MRI contraindication (claustrophobia, patients with metallic foreign bodies)
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 |
|---|---|---|
| MRIHealthy volunteer will have a non-injected cardiovascular MRI | Other | Group 4: healthy volunteer |
| MRI ContrastPatients will have the gadolinium injected cardiovascular MRI | Other | Group 1: patient with paroxysmal AF (Atrial Fibrillation) (no AF during exam), Group 2: patient with persistent AF (Atrial Fibrillation), Group 3: patient with permanent AF (Atrial Fibrillation) |
Primary outcome
Measurement of maximal Left Atrial (LA) longitudinal strain
Time frame: 24 months
Measurement of maximal Left Atrial (LA) longitudinal strain. Comparison between patients and healthy volunteers will allow to define normal values and thresholds for the given sequences.
6 secondary outcomes
Various calibration settings against reference.
Time frame: 24 months
The correlation coefficients from the linear regressions
Time frame: 24 months
The correlation coefficients from the linear regressions
Time frame: 24 months
ROC analysis
Time frame: 24 months
The intra-operator coefficient of variation.
Time frame: 24 months
The inter-operator coefficient of variation.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients with Atrial Fibrillation and Healthy Volunters, run by Assistance Publique - Hôpitaux de Paris.
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 12 inclusion and 12 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: opening soon, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alban Redheuil, MD, PhD (+33142165545 ext. +33, alban.redheuil@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of maximal Left Atrial (LA) longitudinal strain (time frame: 24 months). 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 27 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.