Magnetic Resonance Imaging Development for High Resolution Atrial Structural and Functional Characterization

NCT ID: NCT06617624

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-10-30

Brief 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 morphological, structural and hemodynamic left atrial biomarkers.

Detailed Description

This Magnetic Resonance imaging study of the heart aims to acquire images and measures of:

1. 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.

2. Myocardial tissue characterization including:

1. 3D isotropic ECG-gated with respiratory navigation late gadolinium enhancement (LGE) sequence for high resolution imaging of myocardial injury and fibrosis.

2. 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.

3. 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).

3. 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.

4. 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.

Conditions

Patients with Atrial Fibrillation and Healthy Volunters

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

MRI Contrast

Intervention Type: OTHER

Patients will have the gadolinium injected cardiovascular MRI

Group 2: patient with persistent AF (Atrial Fibrillation)

20 patients able to complete the full standard experimental examination corresponding to persistent AF group

MRI Contrast

Intervention Type: OTHER

Patients will have the gadolinium injected cardiovascular MRI

Group 3: patient with permanent AF (Atrial Fibrillation)

20 patients able to complete the full standard experimental examination corresponding to permanent AF group

MRI Contrast

Intervention Type: OTHER

Patients will have the gadolinium injected cardiovascular MRI

Group 4: healthy volunteer

60 age/sex BMI class matched healthy volunteers, able to complete the full standard experimental examination.

MRI

Intervention Type: OTHER

Healthy volunteer will have a non-injected cardiovascular MRI

Interventions

MRI

Healthy volunteer will have a non-injected cardiovascular MRI

Intervention Type: OTHER

MRI Contrast

Patients will have the gadolinium injected cardiovascular MRI

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alban Redheuil, MD, PhD

Role: CONTACT

alban.redheuil@aphp.fr

+33142165545 ext. +33

Nadjia KACHENOURA, PhD

Role: CONTACT

nadjia.kachenoura@inserm.fr

+33144279116 ext. +33

Other Identifiers

2023-A01951-44

Identifier Type: OTHER

Identifier Source: secondary_id

APHP231076

Identifier Type: -

Identifier Source: org_study_id