HIV InfectionsNCT00889577
Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
An observational study of HIV Infections and Coronary Artery Disease, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Coronary Artery Disease, Non-Alcoholic Fatty Liver Disease
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- HIV patients who participated in our previous Liver Study, conducted at NMCSD, and HIV patients who did not participate in the Liver Study.
Who cannot join
- Women who are pregnant or breastfeeding will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego (NMCSD)
San Diego, California, 92134
About this study
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.
- Medical subject headings
- HIV Infections, Coronary Artery Disease, Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery disease (CAD) measured by the CAC score
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease
Measured: 1 year
To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels
Measured: 1 year
To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Clinical Research Program
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889577
- Sponsor's protocol ID
- IDCRP-018
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2009
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
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.
PubMed 21195379Medina 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.
PubMed 20858081Crum-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.
PubMed 21251186Crum-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.
PubMed 22713476
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Disease and Its Association With Liver Steatosis Among HIV-Infected Persons
- ClinicalTrials.gov ID
- NCT00889577
- Acronym / sponsor ID
- IDCRP-018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Infectious Diseases Clinical Research Program
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- HIV patients who participated in our previous Liver Study, conducted at NMCSD, and HIV patients who did not participate in the Liver Study.
Key exclusion criteria (1 listed)
- Women who are pregnant or breastfeeding will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary artery disease (CAD) measured by the CAC score
Time frame: 1 year
7 secondary outcomes
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
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
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
To assess the relationship between increased pericardial fat on CT scan with visceral fat and cardiovascular disease
Time frame: 1 year
To determine if Hounsfield units taken in the heart and aorta estimates hemoglobin levels
Time frame: 1 year
To measure the pulmonary artery size to evaluate for prevalence of asymptomatic pulmonary hypertension among HIV-infected persons
Time frame: 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Results publicationNorton 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.
- Results publication: PubMed 21195379Crum-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.
- Results publication: PubMed 20858081Medina 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.
- Results publication: PubMed 21251186Crum-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.
- Results publication: PubMed 22713476Crum-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Coronary Artery Disease, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery disease (CAD) measured by the CAC score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889577, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.