Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study (NCT04814420) | Clinical Trial Compass
RecruitingNot Applicable
Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
United States60 participantsStarted 2021-07-12
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
* Inabi…
What they're measuring
1
Percentage of atrial fibrosis in the left atrium measured by DE-MRI