The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Correlation between coronary flow reserve (CFR) and maximum target to background ratio (TBRmax).
研究概览
简要总结
The purpose of this study is to determine whether the use of rosuvastatin in Human Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels, improves blood circulation in the small arteries that provide nutrients to the heart muscle and improves neurocognitive function.
详细描述
HIV is a chronic inflammatory disease. Patients with HIV are at a high risk of cardiovascular disease (CVD) which may be related to this state of chronic inflammation. HIV infected individuals are at up to four times higher risk of suffering a heart attack (also know as acute coronary syndrome).
The medicine rosuvastatin, commonly used to treat high cholesterol, has been shown to reduce inflammation in arteries in the general population and also in patients with high risk for heart problems.
72 subjects with HIV infection will be enrolled and divided into 2 groups of 36.
Group 1: Treatment Group: Participants will receive a low dose of rosuvastatin, 10mg, for 6 months in addition to their current medical therapy.
Group 2: Control Group: Participants will not receive rosuvastatin for 6 months and will continue with their current medical therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-90 years of age
- •documented evidence of HIV infection
- •on standard antiretroviral therapy(ART) for >1 years
- •viral load persistently below the limits of detection while on ART
- •current Cluster of Differentiation Antigen 4 (CD4) count >350 cells/microlitre
- •baseline Framingham risk score of 10-20%
排除标准
- •uncontrolled diabetes mellitus (glycated hemoglobin (HbA1C) >6.5% or fasting glucose >7.0 mmol/L)
- •uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >90)
- •known coronary artery disease (CAD) e.g. previous myocardial infarction, revascularization procedure, or history of angina
- •chronic renal failure (glomerular filtration rate (GFR) <60 ml/min)
- •total cholesterol >5.8 mmol/L
- •Low-density lipoprotein (LDL) cholesterol >4.0 mmol/L
- •already receiving a statin for baseline dyslipidemia
- •pregnant or lactating
- •active untreated Hepatitis B or C
- •diagnosis or clinical evidence of a concomitant inflammatory/autoimmune disease
- •patients at baseline demonstrating regional perfusion abnormalities (confined to individual coronary territories) following stress MCE will be excluded and further management will be according to local best practice guidelines
研究组 & 干预措施
Rosuvastatin
Rosuvastatin 10mg once daily for 6 months.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Correlation between coronary flow reserve (CFR) and maximum target to background ratio (TBRmax).
时间窗: At baseline
At baseline, correlation between CFR by MCE and vascular inflammation (TBRmax) by FDG-PET/CT will be assessed. We anticipate good overall concurrence.
次要结局
- Change in CFR(At 6 months)
- Change in TBRmax.(At 6 months)
- Change in neurocognitive function(At 6 months)
研究者
Gary Small
Associate Professor in Cardiology and Clinician Investigator
Ottawa Heart Institute Research Corporation