Responses of Myocardial Ischemia to Escitalopram Treatment
Information source: Duke University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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:
Shelby N Ladd, B.A., Phone: 919-668-3647, Email: shelby.ladd@duke.edu
Summary
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.
Clinical Details
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 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.
Eligibility
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
Locations and Contacts
Shelby N Ladd, B.A., Phone: 919-668-3647, Email: shelby.ladd@duke.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Shelby N Ladd, B.A., Phone: 919-668-3647, Email: shelby.ladd@duke.edu
Jennifer Wilson, Phone: 919-681-4367, Email: jennifer.wilson@duke.edu
Wei Jiang, M.D., Principal Investigator
Additional Information
Starting date: September 2006
Ending date: September 2012
Last updated: November 12, 2008
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