[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100425016":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":96,"collaborators":40,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":40,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":40,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":58,"whyStopped":40,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Tulane University","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Mild OSA\n\n* 10 patients diagnosed with mild OSA (5\\\u003CAHI\\\u003C15) with no atrial fibrillation.\n* Diagnosis confirmed through polysomnography\\* before enrollment.",[13],"Device: Delayed enhancement magnetic resonance imaging (DE-MRI)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B","Moderate OSA\n\n* 10 patients diagnosed with moderate OSA (15\\\u003CAHI\\\u003C30) with no atrial fibrillation.\n* Diagnosis confirmed through polysomnography\\* before enrollment.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group C","Severe OSA\n\n* 10 patients diagnosed with severe OSA (AHI\\>30) with no atrial fibrillation.\n* Diagnosis confirmed through polysomnography\\* before enrollment.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Group D","Mild OSA and AF\n\n* At least 10 patients diagnosed with mild OSA (5\\\u003CAHI\\\u003C15).\n* Diagnosis confirmed through polysomnography\\* before enrollment.\n* Diagnosed with AF.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Group E","Severe OSA and AF\n\n* At least 10 patients diagnosed with severe OSA (AHI\\>30).\n* Diagnosis confirmed through polysomnography\\* before enrollment.\n* Diagnosed with AF.",[13],{"label":31,"type":6,"description":32,"interventionNames":33},"Group F","Control - No OSA\n\n10 control patients without OSA and without AF.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DEVICE","Delayed enhancement magnetic resonance imaging (DE-MRI)","The patient will be injected with late gadolinium enhancement (0.01 mmol\u002Fkg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions\u002Ftissues 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.",[9,15,19,23,27,31],null,[42],{"name":43,"affiliation":44,"role":45},"Amitabh Pandey, MD","Tulane University School of Medicine","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":40,"email":51},"Christian Massad, MD","CONTACT","504-988-3072","cmassad@tulane.edu",{"name":53,"role":49,"phone":50,"phoneExt":40,"email":54},"Kunal Sameer, MD, MHA","ksameer@tulane.edu",[56,74,85],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"East Jefferson General Hospital","RECRUITING","New Orleans","Louisiana","70006","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-90.07507,29.95465,{"lat":68,"lon":67},[71,72,73],{"name":48,"role":49,"phone":50,"phoneExt":40,"email":51},{"name":53,"role":49,"phone":50,"phoneExt":40,"email":54},{"name":43,"role":45,"phone":40,"phoneExt":40,"email":40},{"facility":75,"status":58,"city":59,"state":60,"zip":76,"country":62,"countryCode":63,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"University Medical Center","70112",{"type":65,"coordinates":78},[67,68],{"lat":68,"lon":67},[81,82,84],{"name":48,"role":49,"phone":50,"phoneExt":40,"email":51},{"name":83,"role":49,"phone":50,"phoneExt":40,"email":54},"Kunal Sameer, MS, MHA",{"name":43,"role":45,"phone":40,"phoneExt":40,"email":40},{"facility":86,"status":58,"city":59,"state":60,"zip":87,"country":62,"countryCode":63,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Tulane Doctors - Speciality Care - Napoleon","70115",{"type":65,"coordinates":89},[67,68],{"lat":68,"lon":67},[92,93,94],{"name":48,"role":49,"phone":50,"phoneExt":40,"email":51},{"name":53,"role":49,"phone":50,"phoneExt":40,"email":54},{"name":95,"role":45,"phone":40,"phoneExt":40,"email":40},"Siddharth Bhansali, MD",{"type":97,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100425016","atrial-fibrosis-in-obstructive-sleep-apnea-patients-a-pilot-study-100425016",false,"NCT04814420","Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study","Inclusion Criteria:\n\nGroup A: 10 patients 18-75-year-old With mild OSA (5\\\u003CAHI\\\u003C15), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup B: 10 patients 18-75-year-old With moderate OSA (15\\\u003CAHI\\\u003C30), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup C: 10 patients 18-75-year-old With severe OSA (AHI\\>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5\\\u003CAHI\\\u003C15), confirmed by polysomnography. Previous AF diagnosis\n\n* In this group, patients with AF and OSA who already have done MRI might be included.\n\nGroup E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI\\>30), confirmed by polysomnography. Previous AF diagnosis\n\n\\*In this group, patients with AF and OSA who already have done MRI might be included.\n\nGroup F (Control): 10 Patients 18-75-year-old No previous OSA and\u002For AF Diagnosis on the medical chart\n\nExclusion Criteria:\n\n* History of chronic heart failure (LVEF \\\u003C 50%), AF, myocardial infarction, valvular disease.\n* Prior cardiac or chest surgery.\n* Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.\n* Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices\u002Fimplants contraindicated for MRI, glomerular filtration rate \\\u003C30 ml\u002Fmin, etc.).\n* Pregnancy.\n* Inability to give informed consent.",true,"ALL","18 Years","75 Years",{"count":109,"type":110},60,"ESTIMATED","INTERVENTIONAL",[113],"NA","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).",[116,117],"Atrial Fibrillation","Obstructive Sleep Apnea",[119,120,121,122],"Ablation","Atrial Fibrosis","Delayed Enhancement Magnetic Resonance Imaging","Electrocardiogram","2026-06-11",{"date":125,"type":126},"2026-06-15","ACTUAL",{"date":128,"type":126},"2021-07-12",{"date":130,"type":110},"2026-11",{"name":5,"class":6},3]