RecruitingNot ApplicableNCT04814420

Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study


Sponsor

Tulane University

Enrollment

60 participants

Start Date

Jul 12, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • Group A: 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. No previous AF diagnosis on the medical chart
  • Group B: 10 patients 18-75-year-old With moderate OSA (15\<AHI\<30), confirmed by polysomnography. No previous AF diagnosis on the medical chart
  • 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\<AHI\<15), confirmed by polysomnography. Previous AF diagnosis
  • 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 Criteria6

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

Interventions

DEVICEDelayed 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.


Locations(3)

East Jefferson General Hospital

New Orleans, Louisiana, United States

University Medical Center

New Orleans, Louisiana, United States

Tulane Doctors - Speciality Care - Napoleon

New Orleans, Louisiana, United States

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NCT04814420


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