Clinical trial NCT04814420: Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
Official title: Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea
Keywords: Ablation
Atrial Fibrosis
Delayed Enhancement Magnetic Resonance Imaging
Electrocardiogram
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty participants would be an adequate sample size for this pilot study to represent all stages of OSA and controls (10 mild, 10 moderate,10 severe OSA with no atrial fibrillation, 10 controls with no OSA and no atrial fibrillation, 10 mild and 10 severe OSA with atrial fibrillation).
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of atrial fibrosis in the left atrium measured by DE-MRI
timeFrame: Baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
Study officials:
affiliation: Tulane University Medical Center
name: Amitabh Pandey, MD
role: PRINCIPAL_INVESTIGATOR
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