Official Title: “Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT Trial)”

Depression is commonly seen in patients with cardiovascular disorders. In recent studies it has been shown that mild to moderate depression symptoms were associated with increased likelihood of mental stress-induced myocardial ischemia (MSIMI), which is a risk factor of poor cardiac outcome. In this project, the investigators aim to assess the treatment of mental stress-induced myocardial ischemia in ischemic heart disease patients with mild to moderate depressive symptoms. This study is a six-week double-blind placebo controlled study to examine the effects of escitalopram on mental stress-induced myocardial ischemia. This study will look to show that patients with ischemic heart disease who are treated with escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to patients receiving placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: September 2012

The goals of this project are to investigate the response of mental stress-induced myocardial ischemia (MSIMI) to escitalopram, an SSRI; to determine whether MSIMI will be reduced by the treatment, and whether the modification of MSIMI is related to improvement of depression symptoms, and/or the reduction of platelet aggregation, and/or the reduction of cardiovascular reactivity. This is a randomized study using escitalopram versus placebo for stable ischemic heart disease patients with MSIMI. This study will also explore the role of platelet activity in occurrence with MSIMI and other characteristics of MSIMI, such as systolic and diastolic function of the left ventricle during mental stress testing as compared to exercise testing.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
• Drug: Placebo
  • Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Escitalopram treatment
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Patients with IHD treated with escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to patients receiving placebo
  • Time Frame: 5 year study - 6 weeks of treatment for each patient
    Safety Issue?: No

Secondary Measures

• Treatment of escitalopram will significantly reduce cardiovascular reactivity during mental stress testing as compared to placebo. Treatment of escitalopram will significantly reduce depression symptoms as compared to placebo
  • Time Frame: 5 year study - 6 weeks of treatment for each patient
    Safety Issue?: No

Inclusion Criteria:

• Age 21 or greater
• Stable ischemic heart disease
• BDI score greater than 4

Exclusion Criteria:

• Recent myocardial infarction, coronary artery bypass graft surgery, or other revascularization procedures (less than 3 months ago)
• LVEF (left ventricular ejection fraction) < 15% measured by echocardiography, RNV, or cardiac catheterization
• Life threatening arrhythmia or arrhythmia interrupting the interpretation of ischemia
• Unable to withdraw from anti-anginal medications during ischemic assessment phase
• Unable to perform exercise testing
• Pregnancy
• Current or previous history of bipolar disorder, cyclothymia, schizophrenia, schizoaffective or schizophreniform disorder, or other psychotic disorders
• Active suicidal ideation
• Current substance abuse or history of substance abuse in the previous 6 months
• Significant cardiac, pulmonary, metabolic, renal, hepatic disease, or malignancy, interfering with patient's participation in this study
• Seizure (history and/or present) with/without treatment
• Currently taking antidepressants that cannot be discontinued

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duke University

Overall Clinical Trial Officials and Contacts

Wei Jiang, M.D. Principal Investigator Duke University  

Overall Contact: Shelby N Ladd, B.A. 919-668-3647 shelby.ladd@duke.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00574847

Study ID Number: 8640-07-8R1ER

ClinicalTrials.gov Identifier: NCT00574847

Health Authority: United States: Institutional Review Board