[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474979":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":133,"collaborators":135,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":11,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":11,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":11,"overallStatus":161,"whyStopped":11,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Kansas City Heart Rhythm Research Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group assigned to receive caffeine","ACTIVE_COMPARATOR",null,[13],"Other: Intravenous caffeine",{"label":15,"type":16,"description":11,"interventionNames":17},"Group assigned to receive masked placebo","PLACEBO_COMPARATOR",[18],"Other: Masked Placebo",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"Intravenous caffeine","Group assigned to receive caffeine will receive intravenous(IV) caffeine and sodium benzoate infusion starting at 250-500 mg.\n\nThis method will use an automated algorithm that adjusts the flow of the infusion depending on the individual's sex and weight and then in a serial fashion in response to blood caffeine measurements. Serial blood caffeine measurements at pre-determined intervals according to the algorithm will be until a steady state is obtained.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Masked Placebo","The patients assigned to the masked placebo will receive 5% dextrose in 0.45% saline using the same infusion protocol for a random length of time that was within 1 standard deviation(SD) of the mean time to achieve a steady state using the caffeine protocol (17+4 min).\n\nTo maintain blinding, caffeine blood concentration measurements that will be randomly generated within 2 SDs of the predicted values calculated by the algorithm will be used and verbally communicated for placebo infusions.",[15],[29],{"name":30,"affiliation":31,"role":32},"Dhanunjaya Lakkireddy","Kansas City Heart Rhythm Institute","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Donita Atkins","CONTACT","816-651-1969","datkins@kchrf.com",[40,56,68,75,83,95,102,113,120],{"facility":41,"status":11,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Loma Linda University","Loma Linda","California","92350","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-117.26115,34.04835,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":11,"phoneExt":11,"email":11},"Jalaj Garg",{"facility":57,"status":11,"city":58,"state":59,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Menorah Medical Center","Overland 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Clinic","Independence","Missouri","64057",{"type":48,"coordinates":89},[90,91],-94.41551,39.09112,{"lat":91,"lon":90},[94],{"name":35,"role":36,"phone":11,"phoneExt":11,"email":11},{"facility":96,"status":11,"city":85,"state":86,"zip":87,"country":45,"countryCode":46,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Centerpoint Medical Center",{"type":48,"coordinates":98},[90,91],{"lat":91,"lon":90},[101],{"name":35,"role":36,"phone":11,"phoneExt":11,"email":11},{"facility":103,"status":11,"city":104,"state":86,"zip":105,"country":45,"countryCode":46,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Research Medical Center Clinic","Kansas City","64032",{"type":48,"coordinates":107},[108,109],-94.57857,39.09973,{"lat":109,"lon":108},[112],{"name":35,"role":36,"phone":11,"phoneExt":11,"email":11},{"facility":114,"status":11,"city":104,"state":86,"zip":105,"country":45,"countryCode":46,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"Research Medical Center",{"type":48,"coordinates":116},[108,109],{"lat":109,"lon":108},[119],{"name":35,"role":36,"phone":11,"phoneExt":11,"email":11},{"facility":121,"status":11,"city":122,"state":123,"zip":124,"country":45,"countryCode":46,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Texas Cardiac Arrythmia Institute","Austin","Texas","78705",{"type":48,"coordinates":126},[127,128],-97.74306,30.26715,{"lat":128,"lon":127},[131],{"name":132,"role":36,"phone":11,"phoneExt":11,"email":11},"Andrea Natale",{"type":134,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[136,137,140],{"name":31,"class":6},{"name":138,"class":139},"Texas Cardiac Arrhythmia Institute, Austin, TX, USA","UNKNOWN",{"name":141,"class":139},"Loma Linda University, Loma Linda, California, USA","100474979","impact-of-intravenous-caffeine-on-atrial-electrical-properties-and-potential-arrythmia-induction-100474979",false,"NCT05464940","Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction","Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial","Inclusion Criteria:\n\nAll adult patients from 21-90 years of age with new onset Paroxysmal Atrial Fibrillation presenting in sinus rhythm or AF of recent onset (the latter confirmed by sinus rhythm documented no more than 1 week prior) undergoing AF ablation will be included in the study.\n\nExclusion Criteria:\n\nPatients will be excluded if any of the following were identified:\n\n1. History of substance abuse or alcoholism.\n2. Left ventricular ejection fraction \\\u003C50%.\n3. Liver dysfunction.\n4. Pregnancy.\n5. Inability to give informed consent.\n6. Amiodarone uses within 1 month prior to procedure.\n7. AAD use within 24 h prior to the procedure\n8. Severe intolerance to caffeine.","ALL","21 Years","90 Years",{"count":153,"type":154},100,"ESTIMATED","INTERVENTIONAL",[157],"NA","This \"How caffeine Induces Atrial Tachyarrhythmias\" trial will be a multi-center, randomized, double-blinded trial of intravenous caffeine versus placebo among patients undergoing pulmonary vein isolation procedures for Atrial Fibrillation(AF).",[160],"Atrial Fibrillation","NOT_YET_RECRUITING","2025-08-27",{"date":164,"type":165},"2025-08-28","ACTUAL",{"date":167,"type":154},"2025-09",{"date":169,"type":154},"2026-06",{"name":5,"class":6},9]