Responses of Myocardial Ischemia to Escitalopram Treatment

Condition(s) targeted: Mental Stress-Induced Myocardial Ischemia

Intervention: Escitalopram (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Wei Jiang, M.D., Principal Investigator, Affiliation: Duke University

Overall contact:
Tamara Foxworth, Phone: 919-668-3647, Email: tamara.foxworth@duke.edu

Depression is commonly seen in patients with cardiovascular disorders, as 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, we 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.

Official title: Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT Trial)

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

Primary outcome: Patients with IHD treated with escitalopram will exhibit a significant improvement of MSIMI at the end of week 6 compared to patients receiving placebo

Secondary outcome: 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

Detailed description: 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 to reduction of platelet aggregation, and/or to 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 of MSIMI and other characteristics of MSIMI, such as systolic and diastolic function of the left ventricle during mental stress testing as comparing to exercise testing.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Tamara Foxworth, Phone: 919-668-3647, Email: tamara.foxworth@duke.edu

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Tamara Foxworth, Phone: 919-668-3647, Email: tamara.foxworth@duke.edu
Jennifer Wilson, Phone: 919-681-4367, Email: jennifer.wilson@duke.edu
Wei Jiang, M.D., Principal Investigator

Starting date: September 2006
Ending date: September 2012
Last updated: December 14, 2007