Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-31 @ 2:07 AM
Study NCT ID:
NCT01088269
Status:
UNKNOWN
Last Update Posted:
2017-09-14
First Post:
2010-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Assessment in Atrial Fibrillation
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Measurement in Atrial Fibrillation,Serum Markers and echocardiographic indexes in atrial fibrillation (AF)', 'timeFrame': 'Baseline', 'description': '1. Evaluation of the oscillometric technique of an electronic device in blood pressure measurement.\n2. Evaluation of the relationship of blood pressure levels with serum markers and ultrasonographic cardiac indexes.\n3. Evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h Holter ECG'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blood Pressure Measurement', 'Atrial Fibrillation', 'Blood pressure measurement in atrial fibrillation', 'Atrial Fibrillation diagnosis'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a cross-sectional study including patients with permanent atrial fibrillation. Assessment will include:\n\n* clinic blood pressure measurements (mercury sphygmomanometer and automated oscillometric device)\n* 24-hour ambulatory blood pressure monitoring\n* determination of various serum markers and cardiac ultrasound.\n* evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h Holter ECG'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'SUBJECTS REFERRED TO HYPERTENSION CENTER', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensives adults in atrial fibrillation\n\nExclusion Criteria:\n\n* Renal disease (Cr \\> 2 mg/l).\n* Patients with pacemaker rhythm during the study.\n* Each patient with acute disease (inflammation, surgery), malignancy, collagen diseases, pulmonary fibrosis, renal failure, liver failure, chronic inflammatory diseases.'}, 'identificationModule': {'nctId': 'NCT01088269', 'briefTitle': 'Blood Pressure Assessment in Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'Evaluation of the Oscillometric Blood Pressure Measurement in Atrial Fibrillation and Relation of Blood Pressure With Serum Biomarkers and Echocardiographic Indexes', 'orgStudyIdInfo': {'id': 'BPM IN AF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AF', 'description': 'Hypertensive patients in AF'}, {'label': 'Non-AF', 'description': 'Hypertensive Patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'George S. Stergiou', 'role': 'CONTACT', 'email': 'gstergi@med.uoa.gr', 'phone': '00302107763117'}, {'name': 'George S. Stergiou, Professor', 'role': 'CONTACT', 'email': 'gstergi@med.uoa.gr', 'phone': '00302017763117'}, {'name': 'Antonios Th. Destounis, Phd candidate', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hypertension Center, Third Internal Medicine Dpt, University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'George S Stergiou, MD', 'role': 'CONTACT', 'email': 'gstergi@med.uoa.gr', 'phone': '+302107763117'}], 'overallOfficials': [{'name': 'George S Stergiou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hypertension Center,Third Department of Medicine,University of Athens,Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine and Hypertension', 'investigatorFullName': 'George S. Stergiou', 'investigatorAffiliation': 'University of Athens'}}}}