Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
NCT04814420 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-03-04
Summary
The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).
Conditions
Interventions
- DEVICE
-
Delayed enhancement magnetic resonance imaging (DE-MRI)
The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.
Sponsors & Collaborators
-
Tulane University
lead OTHER
Principal Investigators
-
Amitabh Pandey, MD · Tulane University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-12
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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