Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
March 20, 2023 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
233
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92134
- Naval Medical Center San Diego (NMCSD)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HIV positive patients who had participated in our previous Liver Study at NMCSD will be given the opportunity to participate in this study, as well as HIV patients who did not participate in the Liver Study.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Coronary artery disease (CAD) measured by the CAC score
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
Time Frame: 1 year
|
1 year
|
|
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
Time Frame: 1 year
|
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
Time Frame: 1 year
|
1 year
|
|
To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease
Time Frame: 1 year
|
1 year
|
|
To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels
Time Frame: 1 year
|
1 year
|
|
To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons
Time Frame: 1 year
|
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.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Norton L, Brodine SK, Medina S, Lemus H, Ricchiuti V, et al. (2013) Adiponectin Levels and Coronary Artery Disease among HIV-Infected Men. J AIDS Clin Res 4: 208.
- Crum-Cianflone N, Stepenosky J, Medina S, Wessman D, Krause D, Boswell G. Clinically significant incidental findings among human immunodeficiency virus-infected men during computed tomography for determination of coronary artery calcium. Am J Cardiol. 2011 Feb 15;107(4):633-7. doi: 10.1016/j.amjcard.2010.10.026. Epub 2010 Dec 31.
- Medina S, Wessman D, Krause D, Stepenosky J, Boswell G, Crum-Cianflone N. Coronary aging in HIV-infected patients. Clin Infect Dis. 2010 Oct 15;51(8):990-3. doi: 10.1086/656442. No abstract available.
- Crum-Cianflone N, Krause D, Wessman D, Medina S, Stepenosky J, Brandt C, Boswell G. Fatty liver disease is associated with underlying cardiovascular disease in HIV-infected persons(*). HIV Med. 2011 Sep;12(8):463-71. doi: 10.1111/j.1468-1293.2010.00904.x. Epub 2011 Jan 20.
- Crum-Cianflone NF, Kathiria N, Shauger S, Love K, Boswell G. The association of epicardial adipose tissue with coronary artery calcification among HIV-infected men. AIDS. 2012 Jul 31;26(12):1573-6. doi: 10.1097/QAD.0b013e328355cef8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
April 28, 2009
First Submitted That Met QC Criteria
April 28, 2009
First Posted (Estimate)
April 29, 2009
Study Record Updates
Last Update Posted (Actual)
March 21, 2023
Last Update Submitted That Met QC Criteria
March 20, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDCRP-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.