[{"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":11,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":11,"eligibilityCriteria":147,"healthyVolunteers":143,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":11,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":11,"overallStatus":160,"whyStopped":11,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"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 Park","Kansas","66209",{"type":48,"coordinates":62},[63,64],-94.67079,38.98223,{"lat":64,"lon":63},[67],{"name":35,"role":36,"phone":11,"phoneExt":11,"email":11},{"facility":31,"status":11,"city":58,"state":59,"zip":69,"country":45,"countryCode":46,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"66211",{"type":48,"coordinates":71},[63,64],{"lat":64,"lon":63},[74],{"name":35,"role":36,"phone":11,"phoneExt":11,"email":11},{"facility":76,"status":11,"city":58,"state":59,"zip":77,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Overland Park Regional Medical Center","66215",{"type":48,"coordinates":79},[63,64],{"lat":64,"lon":63},[82],{"name":35,"role":36,"phone":11,"phoneExt":11,"email":11},{"facility":84,"status":11,"city":85,"state":86,"zip":87,"country":45,"countryCode":46,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Centerpoint Medical Center 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",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":152,"type":153},100,"ESTIMATED","INTERVENTIONAL",[156],"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).",[159],"Atrial Fibrillation","NOT_YET_RECRUITING","2025-08-27",{"date":163,"type":164},"2025-08-28","ACTUAL",{"date":166,"type":153},"2025-09",{"date":168,"type":153},"2026-06",{"name":5,"class":6},9]