Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-04-08 @ 10:43 AM
Study NCT ID:
NCT01317602
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2011-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 603}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2011-03-16', 'studyFirstSubmitQcDate': '2011-03-16', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the management of patients with Atrial Fibrillation.', 'timeFrame': '1 year', 'description': "Evaluation of the use of anticoagulants and antithrombotic drugs. Evaluation of the doctors' compliance with the guidelines."}], 'secondaryOutcomes': [{'measure': 'Evaluation of the risk of strokes.', 'timeFrame': 'Baseline-6month-12months', 'description': 'Evaluation of the risk in a large number of patients using the CHA2DS2-VASc and HAS-BLED scores.'}, {'measure': 'Assessment of morbidity and mortality of patients with AF.', 'timeFrame': '1 year', 'description': 'Assessment of morbidity and mortality of patients with AFduring one year follow-up in comparison with previous results from other registries.'}, {'measure': 'Assessment of the compliance of patients to treatment.', 'timeFrame': 'Baseline-6months-12months', 'description': 'Evaluation of the compliance of patients to treatment and the frequency of visits to their physician especially in terms of achieving therapeutic target INR (TTR, Time in Therapeutic Range).'}, {'measure': 'Assessment of the awareness of patients about the Atrial Fibrillation.', 'timeFrame': 'Baseline', 'description': 'Assessment of the awareness of patients about the Atrial Fibrilation and the potential risk of AF.'}, {'measure': "Assessment of patients' quality of life.", 'timeFrame': 'Baseline-6months-12months', 'description': "Assessment of patients' quality of life (QoL) using a specific questionnaire (EQ - 5D, http://www.euroqol.org) and EHRA score for evaluation of symptoms."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'AF'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, 1-year prospective, observational study of Atrial Fibrillation (AF) in Greece, designed to provide real world data regarding the characteristics of AF patients in Greece, as well as current clinical practices and adherence to the 2010 ESC guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The MANAGE-AF study will enroll 600 consecutive patients from the emergency cardiology departments and outpatient clinics in about 35 Greek hospitals. Their selection will be made in an effort to recruit a representative sample of patients from different geographic areas and stratums of the country.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged ≥ 18 years with any type of AF(first diagnosed, paroxysmal, persistent, long-standing persistent and permanent) according to the classification described in the recent ESC guidelines.\n2. All patients should give written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patients anticipated life expectancy less than 1 year due to a severe concomitant disease.\n2. Participation in an another clinical trial, with the exception of epidemiology trials (observational) that do not influence AF management.\n3. Patients with mental disability unable to comply with follow - up visits and these who are unable to provide, in written, their informed consent or patients with anticipated inability to adhere to scheduled follow up visits.'}, 'identificationModule': {'nctId': 'NCT01317602', 'acronym': 'MANAGE-AF', 'briefTitle': 'Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Cardiovascular Research Society'}, 'officialTitle': 'Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study', 'orgStudyIdInfo': {'id': 'HellenicCardiovascularRS'}}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University Hospital of Alexandroupoli', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': '7th IKA Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Alexandra Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Euroclinic Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens Evangelismos', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Henry Dunant Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'KAT General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Korgialenio Benakio EES Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Laiko General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Sismanoglio General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Ygeia Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Chalcis', 'country': 'Greece', 'facility': 'General Hospital of Chalkida', 'geoPoint': {'lat': 38.46354, 'lon': 23.60284}}, {'city': 'Chania', 'country': 'Greece', 'facility': 'General Hospital of Chania', 'geoPoint': {'lat': 35.51124, 'lon': 24.02921}}, {'city': 'Chios', 'country': 'Greece', 'facility': 'General Hospital of Chios', 'geoPoint': {'lat': 38.36875, 'lon': 26.13718}}, {'city': 'Edessa', 'country': 'Greece', 'facility': 'General Hospital of Edessa', 'geoPoint': {'lat': 40.8026, 'lon': 22.04751}}, {'city': 'Elefsina', 'country': 'Greece', 'facility': 'Thriassio General Hospital of Elefsina', 'geoPoint': {'lat': 38.04135, 'lon': 23.54295}}, {'city': 'Heraklion', 'country': 'Greece', 'facility': 'University Hospital of Heraklion', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'city': 'Heraklio', 'country': 'Greece', 'facility': 'General Hospital Of Heraklio Venizeleio'}, {'city': 'Kavala', 'country': 'Greece', 'facility': 'General Hospital of Kavala', 'geoPoint': {'lat': 40.93959, 'lon': 24.40687}}, {'city': 'Komotini', 'country': 'Greece', 'facility': 'General Hospital of Komotini Sismanoglio', 'geoPoint': {'lat': 41.11758, 'lon': 25.40587}}, {'city': 'Ptolemaida', 'country': 'Greece', 'facility': 'General Hospital of Ptolemaida Mpodosakeio', 'geoPoint': {'lat': 40.51472, 'lon': 21.67861}}, {'city': 'Serres', 'country': 'Greece', 'facility': 'General Hospital of Serres', 'geoPoint': {'lat': 41.08499, 'lon': 23.54757}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': '2nd IKA Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Agios Loukas Clinic', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Ippokrateio Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'University Hospital of Thessaloniki AXEPA', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Volos', 'country': 'Greece', 'facility': 'General Hospital of Volos', 'geoPoint': {'lat': 39.36923, 'lon': 22.94769}}], 'overallOfficials': [{'name': 'Panos E. Vardas, MD, FESC, FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'President, Hellenic Cardiovascular Research Society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Cardiovascular Research Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}