Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-05 @ 8:13 PM
Study NCT ID:
NCT00560534
Status:
COMPLETED
Last Update Posted:
2009-08-19
First Post:
2007-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-18', 'studyFirstSubmitDate': '2007-11-16', 'studyFirstSubmitQcDate': '2007-11-16', 'lastUpdatePostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Magnetic resonance', 'whole body', 'angiography', 'venous compression', 'MRI'], 'conditions': ['Atherosclerosis', 'Intermittent Claudication']}, 'descriptionModule': {'briefSummary': 'To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh.', 'detailedDescription': 'WB-MRA is an examination that can evaluate the arteries from head to feet. Timing of the injected bolus of contrast medium can be difficult, especially in the legs. As the result of the WB-MRA depends on the contrast medium only being in the arteries at the time of examination, the use of venous compression is a possible way of overcoming the problem of early venous filling, that can hamper the diagnostic value of the examination. Venous compression is performed with a blod pressure cuff around the thighs. It is inflated to subsystolic pressure (45 mm Hg). This elevated pressure leads to filling of the lower leg arteries and late venous filling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with peripheral arterial disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic lower extremity ischemia (claudication, ischemic wounds)\n* Referred to digital subtraction angiography (DSA)\n\nExclusion Criteria:\n\n* Renal insufficiency (GFR \\< 30 ml/min)\n* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)\n* Dementia\n* Pregnancy/lactation\n* Allergy to gadolinium based MRI contrast agents\n* Acute disease'}, 'identificationModule': {'nctId': 'NCT00560534', 'briefTitle': 'Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia. Experience With Venous Compression.', 'orgStudyIdInfo': {'id': 'WB-angio herlev 3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Whole body magnetic resonance angiography', 'type': 'PROCEDURE', 'description': 'Magnetic resonance angiography using a paramagnetic contrast agent.Venous compression performed with a blood-pressure cuff around both thighs.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2730', 'city': 'Herlev Copenhagen', 'state': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Radiology, Herlev University Hospital'}], 'overallOfficials': [{'name': 'Henrik S Thomsen, Prof. MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital at Herlev Copenhagen Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Henrik Thomsen', 'oldOrganization': 'Copenhagen University Hospital Herlev'}}}}