Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology
Completed
Conditions studied: HIV, Cardiovascular Disease
In brief
Background: \- 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. Objectives: \- To study metabolism and heart function in people with HIV compared with healthy HIV-negative volunteers. Eligibility: \- Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy HIV-negative volunteers. Design: * 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.
Key facts
- Study ID
- NCT01089114
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 168
- Starts
- 2010-03-08
- Expected to finish
- 2015-08-07
- Last updated by the study team
- 2018-02-14
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or greater
- Documented HIV infection
- Willingness to have stored samples
You may not qualify if…
- Subject is deemed unable to comply with requirements of study participation.
- 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.
- Subjects requiring sedation for MRI studies.
- Subjects with a condition precluding entry into scanner and acquisition of scans (e.g. morbid obesity, claustrophobia, back pain, motion disorders).
- Women who are lactating, pregnant, or actively seeking to become pregnant.
- History of severe allergic reaction to gadolinium contrast agents despite the use of premedication with an anti-histaminic and cortisone.
- Estimated glomerular filtration rate (eGFR) <60 cc/min/1.73m(2).
- Creatinine value >3.0 mg/dl
- For Coronary CTA with Iodine-Based Contrast*:
- 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
- Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:
- Clinically significant asthma
- Active bronchospasm
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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