Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology
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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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Intramyocardial triglyceride
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協力者と研究者
捜査官
- 主任研究者:Colleen M Hadigan, M.D.、National Institute of Allergy and Infectious Diseases (NIAID)
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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