We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01089114
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : October 6, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


- Antiretroviral therapy has increased the lifespan of people with human immunodeficiency virus (HIV), but recent research suggests that people with HIV also have an increased risk of developing cardiovascular disease. To better understand the prevalence and effects of heart disease in people with HIV, researchers are interested in comparing heart imaging and metabolism studies to see if there are differences between HIV-positive and HIV-negative people.


- To study metabolism and heart function in people with HIV compared with healthy HIV-negative volunteers.


- Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy HIV-negative volunteers.


  • Participants will be evaluated with a physical exam, detailed medical history, and routine blood and urine tests including HIV testing.
  • Participants will have the following imaging scans:
  • Cardiac magnetic resonance imaging (MRI) to study the health of the heart and blood vessels
  • Magnetic resonance spectroscopy (MRS) of the heart, liver, and skeletal muscle
  • Cardiac computerized tomography (CT) scan to measure calcium levels in the heart and nearby arteries
  • Dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle mass.
  • Stable isotope infusion to evaluate how the body processes fat (which will require an overnight stay before the test)
  • Participants will also have blood tests, an echocardiogram, and an electrocardiogram to evaluate heart function....

Condition or disease
HIV Cardiovascular Disease

Detailed Description:
HIV is now a chronic infection as patients with access to antiretroviral therapy have significantly improved life expectancies. Patients with HIV also have an increased risk of cardiovascular disease. Thus, cardiovascular disease is an important potential co-morbidity for patients living with HIV. The current proposal will perform a detailed cardiovascular assessment using state-of-the-art imaging techniques to evaluate intramyocardial lipid as well as coronary artery disease and myocardial function in a cohort of 100 HIV infected patients and 30 healthy volunteers as controls. This is an early exploratory cross-sectional study designed to both assess the burden of disease and apply novel techniques in this unique population.

Study Design

Study Type : Observational
Actual Enrollment : 168 participants
Time Perspective: Other
Official Title: Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology
Study Start Date : March 8, 2010
Estimated Study Completion Date : August 7, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Intramyocardial triglyceride

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • HIV-Infected Participants Criteria:


  1. Age 18 years or greater
  2. Documented HIV infection
  3. Willingness to have stored samples


  1. Subject is deemed unable to comply with requirements of study participation.
  2. Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:

    • Implanted cardiac pacemaker or defibrillator
    • Cochlear implants
    • Ocular foreign body (e.g. metal shavings)
    • Embedded shrapnel fragments
    • Central nervous system aneurysm clips
    • Implanted neural stimulator
    • Medical infusion pumps
    • Any implanted device that is incompatible with MRI.
  3. Subjects requiring sedation for MRI studies.
  4. Subjects with a condition precluding entry into scanner and acquisition of scans (e.g. morbid obesity, claustrophobia, back pain, motion disorders).
  5. Women who are lactating, pregnant, or actively seeking to become pregnant.
  6. History of severe allergic reaction to gadolinium contrast agents despite the use of premedication with an anti-histaminic and cortisone.
  7. Estimated glomerular filtration rate (eGFR) <60 cc/min/1.73m(2).
  8. Creatinine value >3.0 mg/dl

For Coronary CTA with Iodine-Based Contrast*:

  1. Contraindication to the use of CT contrast agents:

    • Creatinine value >1.4 mg/dl or eGFR <60 cc/min/1.73m(2).
    • History of multiple myeloma
    • Use of metformin-containing products less than 24 hrs prior to contrast administration
    • History of significant allergic reaction to CT contrast agents
  2. Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:

    • Clinically significant asthma
    • Active bronchospasm
    • Moderate or severe chronic obstructive pulmonary disease (COPD)
    • 2nd or 3rd degree AV block
    • Decompensated cardiac failure
    • Allergy to beta blockers
    • Systolic blood pressure <100 mm Hg
  3. Guidelines for use of beta blocker is outlined in Appendix 1.

    • Participants who are eligible for MRI but who are not eligible for cardiac CT scan will be allowed to participate in the non-CT portion of the study.

Healthy Control Criteria:


  1. Age 18 years or greater
  2. Willingness to have stored samples


All of the exclusion criteria for HIV-infected participants listed above apply to healthy controls. In addition, the following exclusion criteria will also be applied to healthy controls:

  1. Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction) which in the judgment of the investigators would compromise the patient s ability to tolerate this study.
  2. History of or current known cardiovascular disease.
  3. HIV infection.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089114

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Colleen M Hadigan, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01089114     History of Changes
Other Study ID Numbers: 100080
First Posted: March 18, 2010    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: August 7, 2015

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Cardiac Imaging
MR Spectroscopy
Lipid Metabolism
HIV Infection
Cardiovascular Disease
HIV Infections

Additional relevant MeSH terms:
Cardiovascular Diseases