HIV Infections Clinical Trial
Official title:
Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
| NCT number | NCT00889577 |
| Other study ID # | IDCRP-018 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 2008 |
| Est. completion date | December 2013 |
| Verified date | March 2023 |
| Source | Henry M. Jackson Foundation for the Advancement of Military Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 233 |
| Est. completion date | December 2013 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Naval Medical Center San Diego (NMCSD) | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| Henry M. Jackson Foundation for the Advancement of Military Medicine | Infectious Diseases Clinical Research Program |
United States,
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. — View 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. 201 — View 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. — View 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. — View 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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Coronary artery disease (CAD) measured by the CAC score | 1 year | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease | 1 year | ||
| Secondary | To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels | 1 year | ||
| Secondary | To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons | 1 year | ||
| Secondary | 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 |
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