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

NCT06617624 | Not Yet Recruiting

• 2 other identifiers: APHP2310762023-A01951-44
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patients with Atrial Fibrillation and Healthy Volunters

Keywords

Atrial fibrillation; MRI; Acquisition optimisation; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (6)

• Various calibration settings against reference.

  24 months

• The correlation coefficients from the linear regressions

  24 months

• The correlation coefficients from the linear regressions

  24 months

• ROC analysis

  24 months

• The intra-operator coefficient of variation.

  24 months

Study Arms (4)

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

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

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

Other: MRI Contrast

Group 4: healthy volunteer

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

Other: MRI

Interventions

MRI OTHER

Healthy volunteer will have a non-injected cardiovascular MRI

Group 4: healthy volunteer

MRI Contrast OTHER

Patients will have the gadolinium injected cardiovascular MRI

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alban Redheuil, MD, PhD

CONTACT

+33142165545; alban.redheuil@aphp.fr

Nadjia KACHENOURA, PhD

CONTACT

+33144279116; nadjia.kachenoura@inserm.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.