Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Tulane University
Study ID
NCT04814420
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Delayed enhancement magnetic resonance imaging (DE-MRI) — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Jul 12, 2021
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group A
    Mild OSA * 10 patients diagnosed with mild OSA (5\<AHI\<15) with no atrial fibrillation. * Diagnosis confirmed through polysomnography\* before enrollment.
  • Experimental: Group B
    Moderate OSA * 10 patients diagnosed with moderate OSA (15\<AHI\<30) with no atrial fibrillation. * Diagnosis confirmed through polysomnography\* before enrollment.
  • Experimental: Group C
    Severe OSA * 10 patients diagnosed with severe OSA (AHI\>30) with no atrial fibrillation. * Diagnosis confirmed through polysomnography\* before enrollment.
  • 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.
  • 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.
  • Other: Group F
    Control - No OSA 10 control patients without OSA and without AF.

Primary Outcome Measure

Percentage of atrial fibrosis in the left atrium measured by DE-MRI [ Time Frame: Baseline visit ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
East Jefferson General HospitalNew OrleansLouisiana70006
Christian Massad, MD
[email protected]
504-988-3072
Kunal Sameer, MD, MHA
[email protected]
504-988-3072
Amitabh Pandey, MD (PRINCIPAL_INVESTIGATOR)
Tulane Doctors - Speciality Care - NapoleonNew OrleansLouisiana70115
Christian Massad, MD
[email protected]
504-988-3072
Kunal Sameer, MD, MHA
[email protected]
504-988-3072
Siddharth Bhansali, MD (PRINCIPAL_INVESTIGATOR)
University Medical CenterNew OrleansLouisiana70112
Christian Massad, MD
[email protected]
504-988-3072
Kunal Sameer, MS, MHA
[email protected]
504-988-3072
Amitabh Pandey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Orleans, LA

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
East Jefferson General Hospital· New Orleans, LATulane Doctors - Speciality Care - Napoleon· New Orleans, LAUniversity Medical Center· New Orleans, LA

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