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NCT03416257 Clinical Trial

TMAO and Atherosclerosis in HIV

Carotid Artery Plaque Clinical Trial

Official title:
Gut Microbial-related Choline Metabolite Trimethylamine-N-oxide is Associated With Progression of Carotid Artery Atherosclerosis in HIV Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03416257
Other study ID # 2015-5145
Secondary ID K01HL129892
Status Completed
Phase
First received
Last updated
Start date April 12, 2004
Est. completion date April 4, 2017

Study information
Verified date June 2018
Source Albert Einstein College of Medicine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 737
Est. completion date April 4, 2017
Est. primary completion date September 1, 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).

Exclusion Criteria:

- a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Albert Einstein College of Medicine, Inc. National Heart, Lung, and Blood Institute (NHLBI)

Outcome
Type Measure Description Time frame Safety issue
Primary incident carotid artery plaque assessed by repeated B-mode carotid artery ultrasound imaging 2011-2013
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