Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Percentage of atrial fibrosis in the left atrium measured by DE-MRI
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Group A
Mild OSA
- 10 patients diagnosed with mild OSA (5<AHI<15) with no atrial fibrillation.
- Diagnosis confirmed through polysomnography* before enrollment.
干预措施: Delayed enhancement magnetic resonance imaging (DE-MRI) (Device)
Group B
Moderate OSA
- 10 patients diagnosed with moderate OSA (15<AHI<30) with no atrial fibrillation.
- Diagnosis confirmed through polysomnography* before enrollment.
干预措施: Delayed enhancement magnetic resonance imaging (DE-MRI) (Device)
Group C
Severe OSA
- 10 patients diagnosed with severe OSA (AHI>30) with no atrial fibrillation.
- Diagnosis confirmed through polysomnography* before enrollment.
干预措施: Delayed enhancement magnetic resonance imaging (DE-MRI) (Device)
Group D
Mild OSA and AF
- At least 10 patients diagnosed with mild OSA (5<AHI<15).
- Diagnosis confirmed through polysomnography* before enrollment.
- Diagnosed with AF.
干预措施: Delayed enhancement magnetic resonance imaging (DE-MRI) (Device)
Group E
Severe OSA and AF
- At least 10 patients diagnosed with severe OSA (AHI>30).
- Diagnosis confirmed through polysomnography* before enrollment.
- Diagnosed with AF.
干预措施: Delayed enhancement magnetic resonance imaging (DE-MRI) (Device)
Group F
Control - No OSA
10 control patients without OSA and without AF.
干预措施: Delayed enhancement magnetic resonance imaging (DE-MRI) (Device)
结局指标
主要结局
Percentage of atrial fibrosis in the left atrium measured by DE-MRI
时间窗: Baseline visit
DE-MRI purpose is to quantify the degree of atrial structural remodeling or fibrosis Left Atrial Volume Max on MRI measurement reflects atrial load to provide insight into atrial remodeling Left Atrial Volume Min on MRI is important for understanding atrial function, particularly its ability to contract and expel blood into left ventricle Left Atrial Volume Index on MRI is an indicator of left atrial enlargement compared to raw volume measurements Left Atrial Emptying Fraction on MRI is a measure of atrial contractile function. Higher LAEF indicates better atrial function, while lower values can signal impaired atrial mechanics Left Atrial Global Strain on MRI which is the percentage change in myocardial length along the long axis of the left atrium, is calculated using a formula averaging the individual longitudinal strain values from each segment of the myocardium, providing a comprehensive measure of myocardial deformation
次要结局
未报告次要终点