Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-28 @ 2:06 AM
Study NCT ID:
NCT00719992
Status:
COMPLETED
Last Update Posted:
2008-07-22
First Post:
2008-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of HS-CRP in Stable Angina.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-18', 'studyFirstSubmitDate': '2008-07-18', 'studyFirstSubmitQcDate': '2008-07-18', 'lastUpdatePostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'significant coronary lesion'}], 'secondaryOutcomes': [{'measure': 'severity of CAD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Exercise tolerance test', 'HS-CRP', 'Coronary angiography', 'Patients'], 'conditions': ['Stable Angina', 'Positive ETT']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess the amount of additive value of HS-CRP levels to a positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using coronary angiography as the gold standard. The investigators concluded that HS-CRP can be used as a single predictor of coronary vessel involvement in patients with stable angina and positive ETT.', 'detailedDescription': 'the investigators included 97 patients with positive ETT and stable angina and saw that Hs-CRP is the only predictor of severity of CAD as compared with coronary angiography in stable angina patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '43 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable angina\n* Positive ETT\n\nExclusion Criteria:\n\n* Unability to perform ETT\n* Contraindications for ETT and angiography study'}, 'identificationModule': {'nctId': 'NCT00719992', 'briefTitle': 'Diagnostic Value of HS-CRP in Stable Angina.', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Diagnostic Value of HS-CRP in Stable Angina Patients With Positive Exercise Test as Compared With Coronary Angiography.', 'orgStudyIdInfo': {'id': '4543'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'positive ETT, High HS-CRP', 'interventionNames': ['Procedure: coronary angiography']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'positive ETT, Low HS-CRP', 'interventionNames': ['Procedure: coronary angiography']}], 'interventions': [{'name': 'coronary angiography', 'type': 'PROCEDURE', 'description': 'effect of level of HS-CRP', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51318', 'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Cardiology Ward Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'javad kojuri, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shiraz University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Javad Kojuri', 'oldOrganization': 'Shiraz University of medical sciences'}}}}