Does Montelukast Have an Affect on the Function of the Artery in Patients With Heart Disease

Phase

Condition

Cardiac Disease

Chest Pain

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT00351364

18169

Ages 18-80
All Genders

Study Summary

To evaluate the effect of the drug Montelukast on the brachial artery's function. By giving a drug like Montelukast, which blocks the effects of inflammation in the lungs arteries and controls asthma, we hope to see positive effects in other arteries such as in the heart.

Eligibility Criteria

Inclusion

Inclusion Criteria:

male or female age 18-80 years, diagnosis of acute coronary syndrome with oneincreased Troponin assay,chest pain or chest pain syndrome, stable on initial medicaltherapy, painfree x 6 hours prior to enrollment

Exclusion

Exclusion Criteria:

STEMI, Q-wave MI, < 18years, women of childbearing potential, new LBBB, recurrentchest pain since hospitalization, IV nitroglycerine drip, hemodynamically unstable,history of asthma, history of liver disease or abnormal liver enzymes

Study Design

July 01, 2006

July 31, 2010

Study Description

To measure the benefit of cysteinyl leukotriene blockade in favourably altering the pathophysiology of coronary artery disease. We hypothesize that patients admitted to hospital with acute coronary syndromes will have markedly abnormal endothelial function as measured by peripheral vasomotor responses to forearm ischemia. Patients with myocardial infarction and unstable angina have markedly increased renal excretion of the cysteinyl leukotriene metabolite LTE4 as observed in patients with asthma. Observations that coronary vessel tone is negatively affected by leukotrienes C4,D4 and E4 which influences the atherosclerotic process in these arteries. Studies that isolated the epicardial coronary arteries and challenged the vessels with an LTC4 and LTD4 concentration showed that coronary arterial myocytes were found to produce cysteinyl leukotrienes which lead to responsive vasoconstriction. The continued stimulus of vasoconstriction over time leads to endothelial dysfunction and disruption of the endothelium integrity which then leads to stressors that encourage a disease state and atherosclerosis.In this study we will specifically assess peripheral endothelial function by measuring brachial artery diameter changes and PAT responses to temporary forearm ischemia in patients that have had an acute coronary event before and after receiving Montelukast. As well we will measure leukotriene assays both in blood and urine .

Connect with a study center

Foothills Medical Center
Calgary, Alberta T2N 2T9
Canada
Site Not Available

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