Status:
RECRUITING
Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
Lead Sponsor:
Tulane University
Conditions:
Atrial Fibrillation
Obstructive Sleep Apnea
Eligibility:
All Genders
18-75 years
Phase:
NA
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 Delaye...
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 polysomnograp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04814420
Start Date
July 12 2021
End Date
December 1 2025
Last Update
January 28 2025
Active Locations (2)
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1
East Jefferson General Hospital
New Orleans, Louisiana, United States, 70006
2
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112