Conditions: Coronary Heart Disease
Keywords: coronary heart disease montelukast inflammation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 22
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 1 lactose-containing capsule daily for 1 month arm 2: 1 montelukast 10 mg tablet (masked by capsule) daily for 1 month

Interventions: intervention 1: montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg tablet (masked by capsule) daily for 1 month intervention 2: 1 lactose-containing capsule daily for 1 month

Protocol document: