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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on improving MRI scans to better understand the left atrium, which is a part of the heart, in patients with a condition called atrial fibrillation (AF) and in healthy volunteers. The goal is to find the best way to take high-quality images that show the structure and function of the left atrium without taking too much time. This will help doctors measure important heart markers accurately.

To participate, you need to be over 18 years old and meet specific criteria. For patients with atrial fibrillation, you must be involved in another study and able to undergo an MRI. Healthy volunteers also need to be over 18 and free from significant heart problems. If you join this trial, you can expect to have an MRI scan that may involve an injection to enhance the images. It’s important to note that the trial is not yet recruiting participants, so you'll need to wait for it to begin.

Gender

ALL

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
• • 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
• 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