Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- High-sensitivity C-reactive Protein
研究概览
简要总结
The purpose of this study is to determine whether a particular substance involved in inflammation, called leukotrienes, is involved in causing heart disease to occur or to progress.
详细描述
The focus of this study is to better understand why some adults develop heart disease and others do not. There are many known factors which play a role in causing heart disease, such as diet and lifestyle. Also, we know that inflammation, a process in the body which causes painful joints in arthritis or swelling at a site if injury, also contributes to heart disease. In particular, we will address whether leukotrienes, a component of inflammation, is involved in promoting heart disease. We will study this by giving subjects at high risk for heart disease a drug called montelukast which causes leukotrienes to have a reduced effect in the body. In addition for comparison, we will give other subjects a placebo for the same amount of time. These subjects will then be crossed-over and will receive either montelukast or placebo depending on which treatment they received first. We will compare these subjects using blood tests to see if subjects who take montelukast show signs of less inflammation caused by early heart disease as compared to subjects who do not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND
排除标准
- •Current use of lipid-lowering medications
- •Current use of montelukast
- •Poorly controlled hypertension, where systolic blood pressure is greater than 160 or diastolic blood pressure is greater than 100
- •Use of steroid drugs, non-steroidal anti-inflammatory drugs or other anti-inflammatory medications in the two weeks prior to enrollment. (low dose aspirin ( < 325 mg) is OK, but indication must be cardiovascular)
- •Current recreational drug use
- •Other cardiovascular disease or previous cardiovascular event. These include:
- •history of angina pectoris
- •history of heart failure
- •presence of a cardiac pacemaker
- •history of myocardial infarction
- •previous revascularization procedure
- •history cerebrovascular disease including stroke and transient ischemic attack
- •Pregnancy or lactation
- •Diabetes mellitus
- •Lactose intolerance
- •Contraindications to montelukast therapy
- •Alcoholism
- •Known hepatic disease
- •Existing chronic obstructive pulmonary disease, asthma, allergic rhinitis
- •Active chronic immune, infectious, neoplastic or inflammatory diseases requiring therapy (such as active Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV))
- •Immunosuppressant therapy or known immunosuppression due to disease high density lipoprotein (HDL) < 40 mg/dL (although this would be a risk factor for heart disease, because of preliminary data which indicates that montelukast may lower HDL levels, we will exclude patients with abnormally low HDL from study)
- •Other criteria at investigator discretion that are deemed to make the subject a poor candidate for the study
研究组 & 干预措施
Placebo
1 lactose-containing capsule daily for 1 month
干预措施: Placebo (Drug)
Montelukast 10 mg
1 montelukast 10 mg tablet (masked by capsule) daily for 1 month
干预措施: montelukast (Drug)
结局指标
主要结局
High-sensitivity C-reactive Protein
时间窗: 1 month
measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)
次要结局
- High Density Lipoprotein (HDL)-Cholesterol(1 month)