Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-26 @ 11:58 PM
Study NCT ID:
NCT03645902
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2018-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between TOF and SWAN Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Concordance of observed agreement using eSWAN and TOF images measured by Cohen's kappa coefficient", 'timeFrame': 'at inclusion', 'description': 'Concordance of observed agreement for the detection of arterial occlusion between eSWAN and TOF images'}], 'secondaryOutcomes': [{'measure': "Concordance inter-observer agreement for the detection of arterial occlusion using eSWAN images measured by Cohen's kappa coefficient", 'timeFrame': 'at inclusion', 'description': 'Concordance inter-observer agreement between the two readers for the detection of arterial occlusion using eSWAN images'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute stroke', 'Susceptibility-weighted imaging', 'Arterial occlusion', 'Time of flight'], 'conditions': ['Stroke, Acute', 'Angiography', 'Magnetic Resonance Imaging', 'Diagnosis']}, 'descriptionModule': {'briefSummary': 'Optimizing the MRI protocol in acute ischemic stroke remains a challenging issue. In this field, susceptibility-weighted sequences have proved their superiority over T2. Besides the strengthened susceptibility effect, enhanced susceptibility-weighted angiography (eSWAN) sequence provides also a time-of-flight (TOF) effect, allowing the exploration of the intracranial arterial circulation. The objective of this study is to compare eSWAN and 3D TOF, considered as the reference, in the detection of arterial occlusion in acute stroke.', 'detailedDescription': 'Patients who undergo MRI for suspected acute stroke with an acute ischemic lesion on diffusion-weighted imaging (DWI) will be prospectively included in this study.eSWAN and TOF images will be analyzed under double-blind conditions by a junior radiologist and a senior neuroradiologist for the detection of arterial occlusion. eSWAN images will be assessed in order to estimate the inter-observer agreement. After a consensus, eSWAN and TOF data will be compared to calculate inter-modality agreement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients included in this prospective study will be recruited at Saint-Philibert Hospital -Lomme, France, when presenting symptoms of an acute stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical symptoms compatible with acute stroke;\n* time range between symptoms and magnetic resonance imaging less than 4 h 30\n* presence of at least one acute ischemic lesion on the diffusion-weighted images (DWI).\n\nExclusion Criteria:\n\n* MR contraindications;\n* negative DWI;\n* differential diagnosis;\n* incomplete acquisition of the full magnetic resonance imaging protocol or technical issues leading to uninterpretable eSWAN and/or TOF sequences (e.g.motion artifacts).'}, 'identificationModule': {'nctId': 'NCT03645902', 'acronym': 'TOF-SWAN', 'briefTitle': 'Comparison Between TOF and SWAN Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Comparison Between Enhanced Susceptibility-weighted Angiography and Time of Flight Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI', 'orgStudyIdInfo': {'id': 'TOF-SWAN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute stroke patients', 'description': 'MRI examinations will be performed on a 3 T GE MR750 W scanner. Two readers, an experienced neuroradiologist (8 years of experience in neuroradiology) and a junior radiologist (3 years of experience in general radiology) will independently analyze eSWAN and TOF images in random order, looking for arterial occlusions. Analysis will be based on a 2-point-scale: arterial occlusion, based on a local signal loss, or acceptable permeability.', 'interventionNames': ['Diagnostic Test: Magnetic resonance imaging']}], 'interventions': [{'name': 'Magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['Acute stroke patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sebastien Verclytte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GHICL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}