Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
Recruiting · NCT04814420 · Interventional (participants receive a specific treatment) · Lead sponsor: Tulane University
View the official record on ClinicalTrials.gov →Interventions studied
Delayed enhancement magnetic resonance imaging (DE-MRI)
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
3 locations listed across 1 US state.
- 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