Overview

This trial is active, not recruiting.

Condition myocardial ischemia
Treatments escitalopram, placebo
Phase phase 4
Sponsor Duke University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date September 2006
End date September 2014
Trial size 127 participants
Trial identifier NCT00574847, 8640-07-8R1ER, Pro00009555, R01HL085704-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Escitalopram treatment
escitalopram Lexapro
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.
(Placebo Comparator)
Placebo
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.

Primary Outcomes

Measure
Patients with Ischemic Heart Disease (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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 21 years up to 90 years old.

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

Additional Information

Official title Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT Trial)
Principal investigator Wei Jiang, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Duke University.