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Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT)

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ClinicalTrials.gov Identifier: NCT00574847
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : August 5, 2015
Last Update Posted : August 5, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 17, 2007
Results First Submitted Date  ICMJE June 11, 2015
Results First Posted Date  ICMJE August 5, 2015
Last Update Posted Date August 5, 2015
Study Start Date  ICMJE September 2006
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2015)
  • Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors [ Time Frame: Week 6 ]
    MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.
  • Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI) [ Time Frame: week 6 ]
    MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
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 ]
Change History Complete list of historical versions of study NCT00574847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2015)
  • Mental Stress Induced Change of Systolic Blood Pressure [ Time Frame: Baseline, week 6 ]
    Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex.
  • Mental Stress Induced Change of Diastolic Blood Pressure [ Time Frame: Baseline, week 6 ]
    Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex.
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline to week 6 ]
  • Beck Depression Inventory [ Time Frame: 6 week ]
    The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex.
  • Mental Stress Induced Change in Heart Rate [ Time Frame: baseline, 6 weeks ]
    A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs. Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex.
  • 5HTT, Serotonin Transporter Protein [ Time Frame: week 6 ]
    End point values adjusted for baseline values age and sex.
  • Platelet Serotonin Binding Affinity Kd_100 [ Time Frame: 6 weeks ]
    End point values adjusted for baseline values age and sex.
  • Perceived Stress Scale [ Time Frame: 6 weeks ]
    Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex.
  • Cook-Medley Hostility (Ho) Scale [ Time Frame: 6 weeks ]
    Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex.
  • Cook-Medley Hostility (Ho) Hostile Affect Sub-scale [ Time Frame: 6 weeks ]
    hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex.
  • Spielberger State-Trait Anxiety Inventory Scales (STAI) [ Time Frame: 6 weeks ]
    STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex.
  • Exercise Stressed-induced Myocardial Ischemia (ESIMI) [ Time Frame: 6 week ]
    End point values adjusted for baseline values age and sex.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Responses of Myocardial Ischemia to Escitalopram Treatment
Official Title  ICMJE Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT Trial)
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Ischemia
Intervention  ICMJE
  • Drug: Escitalopram
    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 Name: Lexapro
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Escitalopram
    Escitalopram treatment
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
127
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2007)
120
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00574847
Other Study ID Numbers  ICMJE Pro00009555
R01HL085704-01 ( U.S. NIH Grant/Contract )
8640-07-8R1ER ( Other Identifier: Duke legacy protocol number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Wei Jiang, M.D. Duke University
PRS Account Duke University
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP