Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-03 @ 6:13 AM
Study NCT ID:
NCT00561028
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2007-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chlamydia and Mycoplasma in Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D009175', 'term': 'Mycoplasma Infections'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009180', 'term': 'Mycoplasmatales Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample - serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-19', 'studyFirstSubmitDate': '2007-11-19', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test the hypothesis that patients with acute coronary syndromes have higher levels of Chlamydia pneumonia and Mycoplasma pneumonia antibodies in comparison with patients with stable coronary artery disease or controls.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atherosclerosis', 'Coronary artery disease', 'Chlamydia pneumoniae', 'Mycoplasma pneumoniae'], 'conditions': ['Atherosclerosis', 'Coronary Artery Disease', 'Chlamydia Infections', 'Mycoplasma Infections']}, 'referencesModule': {'references': [{'pmid': '19629306', 'type': 'DERIVED', 'citation': 'Maia IL, Nicolau JC, Machado MN, Maia LN, Takakura IT, Rocha PR, Cordeiro JA, Ramires JA. Prevalence of Chlamydia pneumoniae and Mycoplasma pneumoniae in different forms of coronary disease. Arq Bras Cardiol. 2009 Jun;92(6):405-11, 422-8, 439-45. doi: 10.1590/s0066-782x2009000600005. English, Multiple languages.'}]}, 'descriptionModule': {'briefSummary': 'To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies with Acute Coronary Syndromes.', 'detailedDescription': 'One hundred and twenty-six patients were divided into 4 groups: Acute Coronary Syndrome with ST-elevation, Non-ST-elevation, stable coronary artery disease, and individuals without coronary disease. Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured at baseline and after 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1 and 2 - selected after admission in coronary care unit. Group 3 - selected from out-patient cardiology clinic. Group 4 - selected from the blood donation unit.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 yrs\n* Males and females\n* Agreed to sign the informed consent\n\nExclusion Criteria:\n\n* Refusal to sign the informed consent\n* Follow-up not possible\n* For the "acute" groups, time between the pain beginning and randomization \\>24 hours\n* Active infections\n* Use of antimicrobial agents within the last 30 days\n* End-stage diseases with life expectancy \\<6 months'}, 'identificationModule': {'nctId': 'NCT00561028', 'briefTitle': 'Chlamydia and Mycoplasma in Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Base'}, 'officialTitle': 'Prevalence of Chlamydia Pneumoniae and Mycoplasma Pneumoniae in Different Forms of Obstructive Coronary Artery Disease', 'orgStudyIdInfo': {'id': '5105/2001'}, 'secondaryIdInfos': [{'id': '885/02'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'ST-elevation acute myocardial infarction.', 'interventionNames': ['Other: blood sample analysis - mycoplasma and chlamydia antibodies']}, {'label': '2', 'description': 'high-risk unstable angina or non-ST-elevation myocardial infarction.', 'interventionNames': ['Other: blood sample analysis - mycoplasma and chlamydia antibodies']}, {'label': '3', 'description': 'known coronary artery disease, either asymptomatic or with stable angina.', 'interventionNames': ['Other: blood sample analysis - mycoplasma and chlamydia antibodies']}, {'label': '4', 'description': 'blood donors without known coronary artery disease.', 'interventionNames': ['Other: blood sample analysis - mycoplasma and chlamydia antibodies']}], 'interventions': [{'name': 'blood sample analysis - mycoplasma and chlamydia antibodies', 'type': 'OTHER', 'description': 'Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jose C Nicolau, MD, pHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Base', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}]}}}