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Completed

NCT Number: NCT00889577

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

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.

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Key information

Conditions

HIV Infections Arterial Occlusive Diseases Arteriosclerosis Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Coronary Artery Disease Coronary Disease Digestive System Diseases Fatty Liver Genital Diseases Heart Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Myocardial Ischemia Non-Alcoholic Fatty Liver Disease RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Medical Center San Diego (NMCSD)

San Diego, California, 92134, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Coronary artery disease (CAD) measured by the CAC score

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease

    Time frame: 1 year

  5. To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels

    Time frame: 1 year

  6. To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons

    Time frame: 1 year

  7. 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

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • Infectious Diseases Clinical Research Program

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2013
First posted
Apr 29, 2009
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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