Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-22 @ 5:39 PM
Study NCT ID:
NCT01461434
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2011-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graz Study on the Risk of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-20', 'studyFirstSubmitDate': '2011-10-23', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first diagnosis of atrial fibrillation', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Time to change in therapy based on the diagnosis of atrial fibrillation', 'timeFrame': 'Baseline (0 months), 1,2,3,4,5,6,9 and 12 months'}, {'measure': 'Hospitalizations', 'timeFrame': '12 months'}, {'measure': 'Change in NTproBNP serum level associated with occurrence of atrial fibrillation', 'timeFrame': 'Baseline (0 months), 1,2,3,4,5,6,9 and 12 months'}, {'measure': 'Death', 'timeFrame': '12 months'}, {'measure': 'Stroke', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'biomarkers', 'stroke prevention', 'implantable loop recorder'], 'conditions': ['Atrial Fibrillation', 'Hypertension', 'Diabetes', 'Chronic Heart Failure', 'Vascular Disease']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk.\n\nAim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CHA2DS2-VASc risk score \\>= 4\\*\n* 18 years or older\n\nExclusion Criteria:\n\n* known history of atrial fibrillation\n* implanted rhythm device\n* pre-existing indication for oral anticoagulation\n\n(\\*)CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age \\>= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age \\>=65 and \\< 75 years (1 point); Sc - sex category (female) (1 point) ;'}, 'identificationModule': {'nctId': 'NCT01461434', 'acronym': 'GRAF', 'briefTitle': 'Graz Study on the Risk of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients', 'orgStudyIdInfo': {'id': 'GRAF-01-SCCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'loop recorder', 'description': 'patients will be implanted with a subcutaneous loop recorder and have regular follow-ups', 'interventionNames': ['Device: Medtronic Reveal XT implantable loop recorder']}, {'type': 'NO_INTERVENTION', 'label': 'regular follow-up', 'description': 'patients will receive regular follow-ups with standard ECG'}], 'interventions': [{'name': 'Medtronic Reveal XT implantable loop recorder', 'type': 'DEVICE', 'description': 'subcutaneous implantation', 'armGroupLabels': ['loop recorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH/Uniklinikum - Klinische Abteilung für Kardiologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Frank R. Heinzel, MD, PhD', 'investigatorFullName': 'Frank R Heinzel, MD, PhD', 'investigatorAffiliation': 'Medical University of Graz'}}}}