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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Calgary.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Foothills Interventional Cardiology Group
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00351364
First received: July 10, 2006
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Acute Coronary Syndrome
Drug: Montelukast Sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Leukotriene Receptor Blockade on Endothelial Function in Acute Coronary Syndrome Patients

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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. [ Time Frame: 2 hours between baseline and followup ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2006
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug arm - Montelukast
Drug: Montelukast Sodium
100 mg P.O. One time only
Other Name: singular
No Intervention: 2
No drug given

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00351364

Locations
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Foothills Interventional Cardiology Group
Investigators
Principal Investigator: David Goodhart, MD Foothills Medical Center
  More Information

No publications provided

Responsible Party: Todd Anderson, University of Calgary
ClinicalTrials.gov Identifier: NCT00351364     History of Changes
Other Study ID Numbers: 18169
Study First Received: July 10, 2006
Last Updated: January 12, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
atherosclerosis
inflammation
leukotriene blockade
endothelial function

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Syndrome
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014