Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons

Completed

• Conditions: Coronary Artery Disease; Non-Alcoholic Fatty Liver Disease; HIV Infections

• Registration Number: NCT00889577
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief Summary

The primary purpose of this study is to evaluate the association between nonalcoholic fatty liver disease (NAFLD) by computed tomography (CT) scan and coronary artery disease (CAD) measured by the calcium (CAC) score among HIV-infected persons.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2010-03
• Study Completion: 2013-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• HIV patients who participated in our previous Liver Study, conducted at NMCSD, and HIV patients who did not participate in the Liver Study.

Exclusion Criteria

• Women who are pregnant or breastfeeding will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary artery disease (CAD) measured by the CAC score	1 year

Secondary Outcome Measures

Name	Time	Method
To evaluate predictors for coronary artery disease including demographics, concurrent conditions (e.g., diabetes, hyperlipidemia, tobacco use), and HIV factors such as ARV duration, HIV duration, and lipodystrophy	1 year
To investigate the relationship between inflammatory markers (CRP, ESR), d-dimer, adiponectin levels, future inflammatory markers, and genetic polymorphisms with the presence of coronary disease and NAFLD	1 year
To determine the prevalence of coronary artery disease as determined by computed tomography (CT) of the coronary arteries among HIV patients, and to compare it to data from the general population using normative data from recent publications	1 year
To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels	1 year
To describe the outcome of a positive CAC score in terms of follow-up test/procedure results to help describe the clinical significance of elevated scores.	1 year
To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons	1 year
To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease	1 year

Trial Locations

Locations (1)

Naval Medical Center San Diego (NMCSD); 🇺🇸 San Diego, California, United States