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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Infectious Diseases Clinical Research Program
Information provided by (Responsible Party):
Dr. Nancy Crum-Cianflone, Naval Health Research Center
ClinicalTrials.gov Identifier:
NCT00889577
First received: April 28, 2009
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
HIV Infections
Coronary Artery Disease
Non-Alcoholic Fatty Liver Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • Coronary artery disease (CAD) measured by the CAC score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples will be obtained


Estimated Enrollment: 300
Study Start Date: December 2008
Estimated Study Completion Date: January 2015
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889577

Locations
United States, California
Naval Medical Center San Diego (NMCSD)
San Diego, California, United States, 92134
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
  More Information

No publications provided

Responsible Party: Dr. Nancy Crum-Cianflone, Department Head, US Department of Defense Center for Deployment Health Research, Naval Health Research Center
ClinicalTrials.gov Identifier: NCT00889577     History of Changes
Other Study ID Numbers: IDCRP-018
Study First Received: April 28, 2009
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Fatty Liver
Liver Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on March 03, 2013