| December 12, 2007 |
| November 12, 2008 |
| September 2006 |
| September 2012 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| 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 ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00574847 on ClinicalTrials.gov Archive Site |
| 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 ] [ Designated as safety issue: No ] |
| 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 ] [ Designated as safety issue: No ] |
| |
| Responses of Myocardial Ischemia to Escitalopram Treatment |
| 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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
| Myocardial Ischemia |
- Drug: Escitalopram
- Drug: Placebo
|
- Experimental: Escitalopram treatment
- Placebo Comparator: Placebo
|
| |
| |
| Recruiting |
| 120 |
| September 2012 |
| September 2012 (final data collection date for primary outcome measure) |
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
|
| Both |
| 21 Years and older |
| No |
|
|
| United States |
| |
| NCT00574847 |
| Wei Jiang, MD, Duke University Medical Center |
| 8640-07-8R1ER, R01 HL085704-01 |
| Duke University |
|
| Principal Investigator: |
Wei Jiang, M.D. |
Duke University |
|
|
| Duke University |
| November 2008 |
