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

NCT01089114 | Completed

• 2 other identifiers: 10008010-I-0080
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Cardiovascular Disease

Keywords

Cardiac Imaging; MR Spectroscopy; HIV; Lipid Metabolism; HIV Infection; Cardiovascular Disease; HIV Infections

Outcome Measures

Primary Outcomes (1)

• Intramyocardial triglyceride

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• DAD Study Group; Friis-Moller N, Reiss P, Sabin CA, Weber R, Monforte Ad, El-Sadr W, Thiebaut R, De Wit S, Kirk O, Fontas E, Law MG, Phillips A, Lundgren JD. Class of antiretroviral drugs and the risk of myocardial infarction. N Engl J Med. 2007 Apr 26;356(17):1723-35. doi: 10.1056/NEJMoa062744.

  PMID: 17460226 BACKGROUND

• Triant VA, Lee H, Hadigan C, Grinspoon SK. Increased acute myocardial infarction rates and cardiovascular risk factors among patients with human immunodeficiency virus disease. J Clin Endocrinol Metab. 2007 Jul;92(7):2506-12. doi: 10.1210/jc.2006-2190. Epub 2007 Apr 24.

  PMID: 17456578 BACKGROUND

• Hsue PY, Hunt PW, Ho JE, Farah HH, Schnell A, Hoh R, Martin JN, Deeks SG, Bolger AF. Impact of HIV infection on diastolic function and left ventricular mass. Circ Heart Fail. 2010 Jan;3(1):132-9. doi: 10.1161/CIRCHEARTFAILURE.109.854943. Epub 2009 Nov 20.

  PMID: 19933410 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Colleen M Hadigan, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: March 8, 2010
• Study Completion: August 7, 2015
• Last Updated: February 14, 2018

Record last verified: 2015-08-07

Locations

US (1)