Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT03416257
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2018-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TMAO and Atherosclerosis in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 737}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incident carotid artery plaque', 'timeFrame': '2011-2013', 'description': 'assessed by repeated B-mode carotid artery ultrasound imaging'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carotid Artery Plaque']}, 'descriptionModule': {'briefSummary': 'In the present study, the investigators sought to prospectively examine the associations of plasma levels of TMAO (trimethylamine oxide), choline, betaine, dimethylglycine, and sarcosine with risk of incident carotid artery plaque, assessed by repeated B-mode carotid artery ultrasound imaging over a 7-year period, in women and men with and without HIV infection from the WIHS (Women Interagency HIV Study) and MACS (Multicenter Aids Cohort Study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 737 women and men with available baseline plasma choline metabolite data were included in this analysis. There were 520 HIV-infected (291 women, 229 men) and 217 HIV-uninfected (107 women, 110 men) participants included in this study. Baseline characteristics are shownin Table 1. HIV-infected and HIV-uninfected participants were generally similar in terms of demographic and behavioral variables, although HIV-infected participants were more likely to have a history of HCV infection. In addition, HIV-infected participants had lower total cholesterol and HDL cholesterol levels compared to those without HIV infection. The majority of HIV-infected individuals reported using potent ART at baseline (74% in women and 83% in men), and 46% of women and 66% of men had undetectable HIV-1 viral load (≤80 copies/mL). Compared to men, women were younger, more likely to be of black race or Hispanice thnicity and current smokers, and have a history of HCV infection and higher BMI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).\n\nExclusion Criteria:\n\n* a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline'}, 'identificationModule': {'nctId': 'NCT03416257', 'briefTitle': 'TMAO and Atherosclerosis in HIV', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection', 'orgStudyIdInfo': {'id': '2015-5145'}, 'secondaryIdInfos': [{'id': 'K01HL129892', 'link': 'https://reporter.nih.gov/quickSearch/K01HL129892', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'WIHS', 'description': "Women's Interagency HIV Study", 'interventionNames': ['Other: No intervention']}, {'label': 'MACS', 'description': 'Multicenter AIDS Cohort Study', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['MACS', 'WIHS']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Qibin Qi', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}