NCT00889577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

April 28, 2009

Last Update Submit

March 20, 2023

Conditions

HIV InfectionsCoronary Artery DiseaseNon-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Coronary artery disease (CAD) measured by the CAC score

    1 year

Secondary Outcomes (7)

  • 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

  • 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

  • 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

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

    1 year

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

    1 year

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • HIV patients who participated in our previous Liver Study, conducted at NMCSD, and HIV patients who did not participate in the Liver Study.

You may not qualify if:

  • Women who are pregnant or breastfeeding will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center San Diego (NMCSD)

San Diego, California, 92134, United States

Location

Related Publications (5)

  • 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.

    RESULT

  • 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. 2011 Feb 15;107(4):633-7. doi: 10.1016/j.amjcard.2010.10.026. Epub 2010 Dec 31.

    PMID: 21195379RESULT

  • 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.

    PMID: 20858081RESULT

  • 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. Epub 2011 Jan 20.

    PMID: 21251186RESULT

  • 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.

    PMID: 22713476RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained

MeSH Terms

Conditions

HIV InfectionsCoronary Artery DiseaseNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2010

Study Completion

December 1, 2013

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations

US(1)