Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: October 7, 2014
Last verified: October 2014

April 28, 2009
October 7, 2014
December 2008
March 2010   (final data collection date for primary outcome measure)
Coronary artery disease (CAD) measured by the CAC score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00889577 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood samples will be obtained

Non-Probability Sample

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.

  • HIV Infections
  • Coronary Artery Disease
  • Non-Alcoholic Fatty Liver Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
January 2015
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889577
IDCRP-018
Yes
Dr. Nancy Crum-Cianflone, Naval Health Research Center
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
Not Provided
Uniformed Services University of the Health Sciences
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP