Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT03272620
Status:
RECRUITING
Last Update Posted:
2017-09-05
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation at the Viennese University Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-01', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-09-01', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with major adverse cardiac events', 'timeFrame': 'Follow up (10 years)', 'description': 'frequency distribution'}], 'secondaryOutcomes': [{'measure': 'Number of successfully conducted cardioversions', 'timeFrame': 'Follow up (10 years)', 'description': 'frequency distribution'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Atrial Flutter']}, 'referencesModule': {'references': [{'pmid': '11343485', 'type': 'BACKGROUND', 'citation': 'Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.'}, {'pmid': '8018000', 'type': 'BACKGROUND', 'citation': 'Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994 Jul 11;154(13):1449-57.'}, {'pmid': '8297706', 'type': 'BACKGROUND', 'citation': 'Lip GY, Tean KN, Dunn FG. Treatment of atrial fibrillation in a district general hospital. Br Heart J. 1994 Jan;71(1):92-5. doi: 10.1136/hrt.71.1.92.'}, {'pmid': '9737513', 'type': 'BACKGROUND', 'citation': "Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946."}, {'pmid': '22652091', 'type': 'BACKGROUND', 'citation': "O'Reilly DJ, Hopkins RB, Healey JS, Dorian P, Sauriol L, Tarride JE, Burke N, Goeree RA. The burden of atrial fibrillation on the hospital sector in Canada. Can J Cardiol. 2013 Feb;29(2):229-35. doi: 10.1016/j.cjca.2012.03.023. Epub 2012 May 30."}, {'pmid': '10959017', 'type': 'BACKGROUND', 'citation': 'Domanovits H, Schillinger M, Thoennissen J, Nikfardjam M, Janata K, Brunner M, Laggner AN. Termination of recent-onset atrial fibrillation/flutter in the emergency department: a sequential approach with intravenous ibutilide and external electrical cardioversion. Resuscitation. 2000 Aug 1;45(3):181-7. doi: 10.1016/s0300-9572(00)00180-5.'}, {'pmid': '20634022', 'type': 'BACKGROUND', 'citation': 'Vinson DR, Hoehn T, Graber DJ, Williams TM. Managing emergency department patients with recent-onset atrial fibrillation. J Emerg Med. 2012 Feb;42(2):139-48. doi: 10.1016/j.jemermed.2010.05.017. Epub 2010 Jul 15.'}, {'pmid': '22098994', 'type': 'BACKGROUND', 'citation': 'von Besser K, Mills AM. Is discharge to home after emergency department cardioversion safe for the treatment of recent-onset atrial fibrillation? Ann Emerg Med. 2011 Dec;58(6):517-20. doi: 10.1016/j.annemergmed.2011.06.014. Epub 2011 Jul 29.'}, {'pmid': '21422032', 'type': 'BACKGROUND', 'citation': 'Bellone A, Etteri M, Vettorello M, Bonetti C, Clerici D, Gini G, Maino C, Mariani M, Natalizi A, Nessi I, Rampoldi A, Colombo L. Cardioversion of acute atrial fibrillation in the emergency department: a prospective randomised trial. Emerg Med J. 2012 Mar;29(3):188-91. doi: 10.1136/emj.2010.109702. Epub 2011 Mar 21.'}, {'pmid': '21883447', 'type': 'BACKGROUND', 'citation': 'Hochtl T, Huber K. New anticoagulants for the prevention of stroke in atrial fibrillation. Fundam Clin Pharmacol. 2012 Feb;26(1):47-53. doi: 10.1111/j.1472-8206.2011.00982.x. Epub 2011 Aug 29.'}, {'pmid': '24463370', 'type': 'BACKGROUND', 'citation': 'Oldgren J, Healey JS, Ezekowitz M, Commerford P, Avezum A, Pais P, Zhu J, Jansky P, Sigamani A, Morillo CA, Liu L, Damasceno A, Grinvalds A, Nakamya J, Reilly PA, Keltai K, Van Gelder IC, Yusufali AH, Watanabe E, Wallentin L, Connolly SJ, Yusuf S; RE-LY Atrial Fibrillation Registry Investigators. Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: the RE-LY Atrial Fibrillation Registry. Circulation. 2014 Apr 15;129(15):1568-76. doi: 10.1161/CIRCULATIONAHA.113.005451. Epub 2014 Jan 24.'}, {'pmid': '19892303', 'type': 'BACKGROUND', 'citation': 'Rovellini A, Folli C, Cardani F, Monzani V. Thromboembolic and haemorrhagic events in permanent atrial fibrillation: observational study in an emergency department. Eur J Intern Med. 2009 Dec;20(8):756-9. doi: 10.1016/j.ejim.2009.08.008. Epub 2009 Sep 24.'}, {'pmid': '22923145', 'type': 'BACKGROUND', 'citation': 'Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.'}, {'pmid': '35455660', 'type': 'DERIVED', 'citation': 'Niederdockl JD, Simon A, Buchtele N, Schutz N, Cacioppo F, Oppenauer J, Gupta S, Lutnik M, Schnaubelt S, Spiel A, Roth D, Wimbauer F, Fegers-Wustrow I, Esefeld K, Halle M, Scharhag J, Laschitz T, Herkner H, Domanovits H, Schwameis M. Prediction of Successful Pharmacological Cardioversion in Acute Symptomatic Atrial Fibrillation: The Successful Intravenous Cardioversion for Atrial Fibrillation (SIC-AF) Score. J Pers Med. 2022 Mar 30;12(4):544. doi: 10.3390/jpm12040544.'}, {'pmid': '32951957', 'type': 'DERIVED', 'citation': 'Niederdockl J, Simon A, Cacioppo F, Buchtele N, Merrelaar A, Schutz N, Schnaubelt S, Spiel AO, Roth D, Schorgenhofer C, Herkner H, Domanovits H, Schwameis M. Predicting spontaneous conversion to sinus rhythm in symptomatic atrial fibrillation: The ReSinus score. Eur J Intern Med. 2021 Jan;83:45-53. doi: 10.1016/j.ejim.2020.07.022. Epub 2020 Sep 18.'}, {'pmid': '30415208', 'type': 'DERIVED', 'citation': 'Niederdockl J, Simon A, Schnaubelt S, Schuetz N, Laggner R, Sulzgruber P, Spiel AO, Herkner H, Laggner AN, Domanovits H. Cardiac biomarkers predict mortality in emergency patients presenting with atrial fibrillation. Heart. 2019 Mar;105(6):482-488. doi: 10.1136/heartjnl-2018-313145. Epub 2018 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'The results of this study could imply that a atrial fibrillation registry, as a tool for structured diagnosis and therapy in patients with atrial fibrillation, may improve patient care for this rapidly growing population.', 'detailedDescription': 'Atrial fibrillation is the most common cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality, with stroke being an especially important and potentially devastating complication. The number of patients with atrial fibrillation is likely to increase 2.5-fold during the next 50 years, reflecting the growing proportion of elderly individuals. Emergency departments play a central role in diagnosis and treatment (rhythm and rate control, initiation of anticoagulatory therapy for stroke prevention) of atrial fibrillation. Additionally, embolic (e.g. stroke, mesenteric ischemia) complications of atrial fibrillation and bleeding complications (e.g. gastrointestinal and intracranial) of anticoagulatory therapy are likewise treated at emergency departments.\n\nTherefor the investigators hypothesis implies that the atrial fibrillation registry could serve as a tool for structured diagnosis and therapy in patients with atrial fibrillation and therefore may improve patient care. Additionally, diagnostic and therapeutic shortcomings by analyzing registry data may be detected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atrial fibrillation treated at the Emergency Department of the Vienna Medical University. Currently, about 600 patients with atrial fibrillation are seen annually at the Emergency Department, every patient with atrial fibrillation treated at the Emergency Department should be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atrial fibrillation treated at the Emergency Department of the Medical University of Vienna\n* Signed consent\n\nExclusion Criteria:\n\n* Inclusion criteria not met'}, 'identificationModule': {'nctId': 'NCT03272620', 'briefTitle': 'Atrial Fibrillation at the Viennese University Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Atrial Fibrillation Registry at the Emergency Department of the Medical University of Vienna: A Tool for Structured Diagnosis and Treatment', 'orgStudyIdInfo': {'id': '98765'}}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Jan Niederdöckl, Dr.', 'role': 'CONTACT', 'email': 'jan.niederdoeckl@medunwien.ac.at'}, {'name': 'Alexander Simon, Dr.', 'role': 'CONTACT', 'email': 'alexander.simon@medunwien.ac.at'}], 'facility': 'Emergency Department, Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Jan Niederdöckl, Dr.', 'role': 'CONTACT', 'email': 'jan.niederdöckl@meduniwien.ac.at'}, {'name': 'Alexander Simon, Dr.', 'role': 'CONTACT', 'email': 'alexander.simon@meduniwien.ac.at'}], 'overallOfficials': [{'name': 'Alexander Spiel, Priv. Doz.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor at the Department of Emergency Medicine', 'investigatorFullName': 'Alexander Spiel', 'investigatorAffiliation': 'Medical University of Vienna'}}}}