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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT01089114

Collaborator

(none)

168

Enrollment

Location

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 :

Mar 8, 2010

Study Completion Date :

Aug 7, 2015

Outcome Measures

Primary Outcome Measures

Intramyocardial triglyceride []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

HIV-Infected Participants Criteria:

INCLUSION CRITERIA:

Age 18 years or greater
Documented HIV infection
Willingness to have stored samples

EXCLUSION CRITERIA:

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
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

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:

INCLUSION CRITERIA:

Age 18 years or greater
Willingness to have stored samples

EXCLUSION CRITERIA:

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:

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.
History of or current known cardiovascular disease.
HIV infection.