Clinical trial NCT00889577: Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
Official title: Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Coronary Artery Disease
Non-Alcoholic Fatty Liver Disease
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Clinical Research Program
First posted: 2009-04-29
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Coronary artery disease (CAD) measured by the CAC score
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease
timeFrame: 1 year
measure: To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels
timeFrame: 1 year
measure: To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego (NMCSD)
state: California
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.