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

Tracking Information
First Received Date ^ICMJE	April 28, 2009
Last Updated Date	January 18, 2013
Start Date ^ICMJE	December 2008
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 28, 2009)	Coronary artery disease (CAD) measured by the CAC score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00889577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 6, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: April 28, 2009)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
Official Title ^ICMJE	Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Blood samples will be obtained
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.
Condition ^ICMJE	HIV Infections Coronary Artery Disease Non-Alcoholic Fatty Liver Disease
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	300
Estimated Completion Date	January 2015
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00889577
Other Study ID Numbers ^ICMJE	IDCRP-018
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Nancy Crum-Cianflone, Naval Health Research Center
Study Sponsor ^ICMJE	Uniformed Services University of the Health Sciences
Collaborators ^ICMJE	Infectious Diseases Clinical Research Program
Investigators ^ICMJE	Not Provided
Information Provided By	Uniformed Services University of the Health Sciences
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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