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Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
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
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A 		Mild OSA - 10 patients diagnosed with mild OSA (5<AHI<15) with no atrial fibrillation. - Diagnosis confirmed through polysomnography* before enrollment.
  • Device: Delayed enhancement magnetic resonance imaging (DE-MRI)
    The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.
Experimental
Group B 		Moderate OSA - 10 patients diagnosed with moderate OSA (15<AHI<30) with no atrial fibrillation. - Diagnosis confirmed through polysomnography* before enrollment.
  • Device: Delayed enhancement magnetic resonance imaging (DE-MRI)
    The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.
Experimental
Group C 		Severe OSA - 10 patients diagnosed with severe OSA (AHI>30) with no atrial fibrillation. - Diagnosis confirmed through polysomnography* before enrollment.
  • Device: Delayed enhancement magnetic resonance imaging (DE-MRI)
    The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.
Experimental
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.
  • Device: Delayed enhancement magnetic resonance imaging (DE-MRI)
    The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.
Experimental
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.
  • Device: Delayed enhancement magnetic resonance imaging (DE-MRI)
    The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.
Other
Group F 		Control - No OSA 10 control patients without OSA and without AF.
  • Device: Delayed enhancement magnetic resonance imaging (DE-MRI)
    The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.

Recruiting Locations

Tulane University Medical Center
New Orleans, Louisiana 70112
Contact:
Quintrele Jones, MPH
504-988-3063
qjones1@tulane.edu

East Jefferson General Hospital
New Orleans, Louisiana 70006
Contact:
Quintrele Jones, MPH
504-988-3063
qjones1@tulane.edu

More Details

Status
Recruiting
Sponsor
Tulane University

Study Contact

Quintrele Jones, MPH
504-988-3063
qjones1@tulane.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.