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

Primary Purpose

Coronary Artery Disease, Acute Coronary Syndrome

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Montelukast Sodium
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring atherosclerosis, inflammation, leukotriene blockade, endothelial function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: male or female age 18-80 years, diagnosis of acute coronary syndrome with one increased Troponin assay,chest pain or chest pain syndrome, stable on initial medical therapy, painfree x 6 hours prior to enrollment Exclusion Criteria: STEMI, Q-wave MI, < 18years, women of childbearing potential, new LBBB, recurrent chest pain since hospitalization, IV nitroglycerine drip, hemodynamically unstable, history of asthma, history of liver disease or abnormal liver enzymes

Sites / Locations

  • Foothills Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Montelukast sodium

2

Arm Description

Drug arm - Montelukast as a single dose 100 mg. To test the hypothesis of leukotriene inhibition.

No drug given - no placebo available. To compare with active drug.

Outcomes

Primary Outcome Measures

The degree of brachial artery flow mediated dilation achieved compared between the control and interventional conditions.

Secondary Outcome Measures

The degree of RH-PAT mediated dilation as a ratio of PVA during reactive hyperemia/ baseline PVA index will be compared between the control and Interventional conditions.

Full Information

First Posted
July 10, 2006
Last Updated
December 1, 2014
Sponsor
University of Calgary
Collaborators
Foothills Interventional Cardiology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00351364
Brief Title
Does Montelukast Have an Affect on the Function of the Artery in Patients With Heart Disease
Official Title
The Effect of Leukotriene Receptor Blockade on Endothelial Function in Acute Coronary Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Diffic;ulty recruiting
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Foothills Interventional Cardiology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Coronary Syndrome
Keywords
atherosclerosis, inflammation, leukotriene blockade, endothelial function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montelukast sodium
Arm Type
Active Comparator
Arm Description
Drug arm - Montelukast as a single dose 100 mg. To test the hypothesis of leukotriene inhibition.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
No drug given - no placebo available. To compare with active drug.
Intervention Type
Drug
Intervention Name(s)
Montelukast Sodium
Other Intervention Name(s)
singular
Intervention Description
100 mg P.O. One time only
Primary Outcome Measure Information:
Title
The degree of brachial artery flow mediated dilation achieved compared between the control and interventional conditions.
Time Frame
2 hours between baseline and follow up
Secondary Outcome Measure Information:
Title
The degree of RH-PAT mediated dilation as a ratio of PVA during reactive hyperemia/ baseline PVA index will be compared between the control and Interventional conditions.
Time Frame
2 hours between baseline and followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male or female age 18-80 years, diagnosis of acute coronary syndrome with one increased Troponin assay,chest pain or chest pain syndrome, stable on initial medical therapy, painfree x 6 hours prior to enrollment Exclusion Criteria: STEMI, Q-wave MI, < 18years, women of childbearing potential, new LBBB, recurrent chest pain since hospitalization, IV nitroglycerine drip, hemodynamically unstable, history of asthma, history of liver disease or abnormal liver enzymes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Goodhart, MD
Organizational Affiliation
Foothills Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada

12. IPD Sharing Statement

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

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