Responses of Myocardial Ischemia to Escitalopram Treatment
| Status: | Completed |
|---|---|
| Conditions: | Angina, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | September 2006 |
| End Date: | November 2011 |
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.
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.
The goals of this project are to investigate the response of mental stress-induced
myocardial ischemia (MSIMI) to escitalopram, a selective serotonin reuptake inhibitor
(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.
The stress testing will be conducted at the Duke Cardiology Diagnostic Unit Laboratory.
Following a 20-minute calibration-rest period, participants will be asked to complete a
series of 3 mental stress tasks. There are 3 mental stress tasks to be used for this study,
i.e., (1) Mental arithmetic: during this test, patients will be asked to perform a series of
serial subtractions beginning at a given number which will be different for each repeated
test and will be chosen by the tester from a fixed list of various numbers, with
encouragement to perform calculations as quickly as possible; (2) Public speaking with anger
recall: during this test, patients will be asked to give a speech on a recent situation in
which they experienced anger to an audience of observers (two to three) after 1 minute of
preparation. Prior to the speech, subjects are told that their speech will be evaluated on
their description of the situation, as to what happened, what they thought, felt, what they
did, and what happened as a result. If they run out of things to say, the research tech will
prompt them with questions to elicit more content until the three minutes are up; (3) Mirror
trace: during this test, patients will be asked to outline, as quickly as possible, a star
from its reflection in a mirror. Each task will last 3 minutes and there will be a 6-minute
rest period between tasks.
myocardial ischemia (MSIMI) to escitalopram, a selective serotonin reuptake inhibitor
(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.
The stress testing will be conducted at the Duke Cardiology Diagnostic Unit Laboratory.
Following a 20-minute calibration-rest period, participants will be asked to complete a
series of 3 mental stress tasks. There are 3 mental stress tasks to be used for this study,
i.e., (1) Mental arithmetic: during this test, patients will be asked to perform a series of
serial subtractions beginning at a given number which will be different for each repeated
test and will be chosen by the tester from a fixed list of various numbers, with
encouragement to perform calculations as quickly as possible; (2) Public speaking with anger
recall: during this test, patients will be asked to give a speech on a recent situation in
which they experienced anger to an audience of observers (two to three) after 1 minute of
preparation. Prior to the speech, subjects are told that their speech will be evaluated on
their description of the situation, as to what happened, what they thought, felt, what they
did, and what happened as a result. If they run out of things to say, the research tech will
prompt them with questions to elicit more content until the three minutes are up; (3) Mirror
trace: during this test, patients will be asked to outline, as quickly as possible, a star
from its reflection in a mirror. Each task will last 3 minutes and there will be a 6-minute
rest period between tasks.
Inclusion Criteria:
- Age 21 or greater, less than 90
- Stable ischemic heart disease
Exclusion Criteria:
- Recent myocardial infarction, coronary artery bypass graft surgery, or other
revascularization procedures (less than 3 months ago)
- Left ventricular ejection fraction(LVEF) < 15% measured by echocardiography,
radionuclide ventriculography (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
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