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

NCT00351364 | Terminated Phase 4 DMC

• 1 other identifier: 18169
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Keywords

atherosclerosis; inflammation; leukotriene blockade; endothelial function

Outcome Measures

Primary Outcomes (1)

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

  2 hours between baseline and follow up

Secondary Outcomes (1)

• 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.

  2 hours between baseline and followup

Study Arms (2)

Montelukast sodium

ACTIVE COMPARATOR

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

Drug: Montelukast Sodium

2

PLACEBO COMPARATOR

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

Drug: Montelukast Sodium

Interventions

Montelukast Sodium DRUG

100 mg P.O. One time only

Also known as: singular

2; Montelukast sodium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Foothills Interventional Cardiology Group: collaborator

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Atherosclerosis; Inflammation

Interventions

montelukast; Single Person

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• David Goodhart, MD

  Foothills Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Libin Cardiovascular Institute

Study Record Dates

• First Submitted: July 10, 2006
• First Posted: July 12, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CA (1)