Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-05 @ 8:42 AM
Study NCT ID:
NCT00519961
Status:
UNKNOWN
Last Update Posted:
2011-03-16
First Post:
2007-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Brazil', 'France', 'Italy', 'Poland', 'Serbia', 'Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-15', 'studyFirstSubmitDate': '2007-08-22', 'studyFirstSubmitQcDate': '2007-08-22', 'lastUpdatePostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of 30-day and 1-year postoperative cardiac events', 'timeFrame': '30-day and 1-year postoperation'}]}, 'conditionsModule': {'conditions': ['Peripheral Vascular Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to validate the screening potential of NT-proBNP for the identification of patients scheduled for vascular surgery who would benefit from additional pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured pre-operatively. For low-intermediate risk patients only those with abnormal values will receive further cardiac testing; all high risk patients will be referred for additional testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\≥18 years of age\n* Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT00519961', 'briefTitle': 'A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery', 'orgStudyIdInfo': {'id': 'RD000485'}, 'secondaryIdInfos': [{'id': 'DECREASE-VI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Device: Elecsys®proBNP']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Device: Elecsys®proBNP']}], 'interventions': [{'name': 'Elecsys®proBNP', 'type': 'DEVICE', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D4', 'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '3000 CA', 'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Roche Diagnostics Center', 'role': 'CONTACT', 'email': 'Dia_StudyInquiries@Roche.com', 'phone': '1-866-805-5919 (U.S. Only)'}], 'overallOfficials': [{'name': 'Wilma Verhagen-Kamerbeek', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Roche Diagnostics GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Disclosures Group', 'oldOrganization': 'Hoffmann-La Roche'}}}}