Responses of Myocardial Ischemia to Escitalopram Treatment
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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.

      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.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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 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.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ischemic heart disease; mental stress-induced myocardial ischemia; escitalopram