Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study

Last updated: January 23, 2025
Sponsor: Tulane University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Sleep Apnea Syndromes

Cardiac Disease

Treatment

Delayed enhancement magnetic resonance imaging (DE-MRI)

Clinical Study ID

NCT04814420
2019-2081
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Group A: 10 patients 18-75-year-old With mild OSA (5

Group B: 10 patients 18-75-year-old With moderate OSA (15

Group C: 10 patients 18-75-year-old With severe OSA (AHI>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5

  • In this group, patients with AF and OSA who already have done MRI might be included.

Group E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI>30), confirmed by polysomnography. Previous AF diagnosis

*In this group, patients with AF and OSA who already have done MRI might be included.

Group F (Control): 10 Patients 18-75-year-old No previous OSA and/or AF Diagnosis on the medical chart

Exclusion

Exclusion Criteria:

  • History of chronic heart failure (LVEF < 50%), AF, myocardial infarction, valvulardisease.

  • Prior cardiac or chest surgery.

  • Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.

  • Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices/implants contraindicated for MRI, glomerular filtration rate <30 ml/min, etc.).

  • Pregnancy.

  • Inability to give informed consent.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Delayed enhancement magnetic resonance imaging (DE-MRI)
Phase:
Study Start date:
July 12, 2021
Estimated Completion Date:
December 31, 2025

Study Description

This is a cross sectional pilot study. Sixty mild to severe OSA patients and five age- and Body Mass Index (BMI)-matched controls will undergo a DE-MRI. Demographics, medical history and polysomnography results will be collected. Patients diagnosed with obstructive sleep apnea have undergone a polysomnography before the study and were diagnosed based on this test. The investigators will not be performing a polysomnography for any of the patients, just collecting the previous results from their medical charts to confirm they have a true OSA diagnosis for their inclusion in the study.

Connect with a study center

  • East Jefferson General Hospital

    New Orleans, Louisiana 70006
    United States

    Active - Recruiting

  • Tulane University Medical Center

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

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