Immune Correlates of Cardiac Structure and Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging
研究概览
简要总结
The purpose of this study is to determine the occurrence of scarring of the heart (cardiac fibrosis) and inflammation in those with perinatally acquired Human Immunodeficiency Virus (HIV) infection compared to people not infected with HIV. The information learned from this research may help the investigator to better understand the link between cardiac fibrosis and cardiac dysfunction and inflammation in those with perinatally acquired HIV infection compared to the uninfected.
Participants will have a blood sample, complete a patient questionnaire, and have a Magnetic resonance imaging (MRI) and ultrasound of the heart.
Researchers will review the medical record and past medical history, for information about your heart function and overall health. Research samples and data from this study will be stored indefinitely and used for other research.
There are risks to participate in this study and those risks include side effects from the contrast agent used for the MRI scan, (such as headache and injection site pain), and risks from blood sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 20-45 years of age
- •Willingness and ability to provide signed and dated written informed consent, prior to any study-related procedures
- •Diagnosed with HIV <10 years of age or physician confirmation of perinatal HIV infection
- •On antiretroviral treatment (ART) for at least the last greater than or equal to 6 months
- •Willingness to undergo Cardiovascular magnetic resonance imaging (CMR)
- •Willingness to undergo echocardiogram (ECHO) (may be included if ECHO has been done at Duke in the previous 24 months).
- •Willingness to have research blood draw
排除标准
- •Contraindication to CMR (metal fragments in eyes or face, implanted electronic devices such as pacemakers, defibrillators, cochlear implants, or nerve stimulators, aneurysm clips)
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
- •History of anaphylactic reaction to gadolinium contrast
- •Inability to complete an MRI scan in the past due to anxiety
- •Recent acute medical illness resulting in recent hospitalization (in past 90 days)
- •History of: Coronary artery disease (CAD), Myocardial infarction (MI), moderate-severe valvular disease, congenital heart disease, heart failure, non-ischemic CM, Atrial fibrillation/flutter, implantable cardioverter defibrillator (ICD)/pacemaker, myocarditis prior
- •Current Symptoms of Shortness of breath, severe chest pain, palpations, difficulty breathing on exertion, swelling of legs
- •Known to be pregnant or current breastfeeding
- •Known to be on hemodialysis
- •Inability to breath hold for 5-10 seconds
- •Known to have an ejection fraction <45% in the past 24 months
- •Active cancer or cancer chemotherapy or radiation treatment in the prior year.
- •Comorbid inflammatory disease, specifically treated for rheumatoid arthritis (RA) or lupus (SLE)
- •Chronic use of steroids or anti-inflammatory therapy
结局指标
主要结局
Myocardial fibrosis by cardiac magnetic resonance (CMR) imaging
时间窗: Baseline Visit
Compare myocardial fibrosis for HIV+ and control subjects (unit = percentage)
次要结局
- Cardiac function evaluated using cine cardiac magnetic resonance imaging(Baseline Visit)
- Myocardial edema evaluated using native T2 mapping cardiac magnetic resonance imaging(Baseline Visit)
- Diffuse fibrosis evaluated using native T1 mapping cardiac magnetic resonance imaging(Baseline Visit)
- Extra-cellular volume (ECV) cardiac magnetic resonance imaging(Baseline Visit)