Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT01532167
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2012-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact and Utility of PET Versus Clinical Score for the Assessment of Inflammatory Activity in Takayasu Arteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013625', 'term': 'Takayasu Arteritis'}], 'ancestors': [{'id': 'D001015', 'term': 'Aortic Arch Syndromes'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2012-02-08', 'studyFirstSubmitQcDate': '2012-02-13', 'lastUpdatePostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Takayasu Arteritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that \\[18F\\]FDG PET is a a better method than clinical and laboratory values for the identification and assessment of inflammatory activity in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a precise evaluation of response to therapy.', 'detailedDescription': "Inflammatory activity and fibrosis are the main causes of morbidity and mortality in patients with Takayasu arteritis. The investigators objective is to determine the utility of using 18F-FDG PET in the basal evaluation and follow-up of patients and compare the results with Dabague's clinical score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients treated for TA at our institution's immunology outpatient clinic were included between.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TA was diagnosed if the patient met 3 or more ACR criteria.'}, 'identificationModule': {'nctId': 'NCT01532167', 'briefTitle': 'Impact and Utility of PET Versus Clinical Score for the Assessment of Inflammatory Activity in Takayasu Arteritis', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cardiologia Ignacio Chavez'}, 'officialTitle': 'Impact and Utility of Positron Emission Tomography (PET) for the Assessment of Inflammatory Activity Arteritis Versus Clinical Score and Laboratory Values in Takayasu Arteritis: a Cohort Study', 'orgStudyIdInfo': {'id': '12-755'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cardiologia', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Maria E Soto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Cardiologia'}, {'name': 'Erick Alexanderson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto Nacional de Cardiologia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cardiologia Ignacio Chavez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Jose Telich', 'investigatorAffiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez'}}}}