Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351364
Status:
TERMINATED
Last Update Posted:
2014-12-03
First Post:
2006-07-10
Brief Title:
Does Montelukast Have an Affect on the Function of the Artery in Patients With Heart Disease
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
The Effect of Leukotriene Receptor Blockade on Endothelial Function in Acute Coronary Syndrome Patients
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the effect of the drug Montelukast on the brachial arterys 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
Detailed 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 C4D4 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 atherosclerosisIn 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None