Responses of Myocardial Ischemia to Escitalopram Treatment

NCT00574847 | Completed Phase 4 Results DMC

• 3 other identifiers: Pro00009555R01HL085704-018640-07-8R1ER
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia

Keywords

ischemic heart disease; mental stress-induced myocardial ischemia; escitalopram

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors

  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.

  Week 6

• Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)

  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.

  week 6

Secondary Outcomes (12)

• Mental Stress Induced Change of Systolic Blood Pressure

  Baseline, week 6

• Mental Stress Induced Change of Diastolic Blood Pressure

  Baseline, week 6

• Percentage of Participants With Adverse Events

  Baseline to week 6

• Beck Depression Inventory

  6 week

• Mental Stress Induced Change in Heart Rate

  baseline, 6 weeks

Study Arms (2)

Escitalopram

EXPERIMENTAL

Escitalopram treatment

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Escitalopram

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 or greater, less than 90
• Stable ischemic heart disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (6)

• Jiang W, Velazquez EJ, Samad Z, Kuchibhatla M, Martsberger C, Rogers J, Williams R, Kuhn C, Ortel TL, Becker RC, Pristera N, Krishnan R, O'Connor CM. Responses of mental stress-induced myocardial ischemia to escitalopram treatment: background, design, and method for the Responses of Mental Stress Induced Myocardial Ischemia to Escitalopram Treatment trial. Am Heart J. 2012 Jan;163(1):20-6. doi: 10.1016/j.ahj.2011.09.018. Epub 2011 Nov 14.

  PMID: 22172432 BACKGROUND

• Samad Z, Boyle S, Ersboll M, Vora AN, Zhang Y, Becker RC, Williams R, Kuhn C, Ortel TL, Rogers JG, O'Connor CM, Velazquez EJ, Jiang W; REMIT Investigators. Sex differences in platelet reactivity and cardiovascular and psychological response to mental stress in patients with stable ischemic heart disease: insights from the REMIT study. J Am Coll Cardiol. 2014 Oct 21;64(16):1669-78. doi: 10.1016/j.jacc.2014.04.087.

  PMID: 25323254 DERIVED

• Ersboll M, Al Enezi F, Samad Z, Sedberry B, Boyle SH, O'Connor C, Jiang W, Velazquez EJ; REMIT Investigators. Impaired resting myocardial annular velocities are independently associated with mental stress-induced ischemia in coronary heart disease. JACC Cardiovasc Imaging. 2014 Apr;7(4):351-61. doi: 10.1016/j.jcmg.2013.10.014. Epub 2014 Mar 13.

  PMID: 24631512 DERIVED

• Boyle SH, Samad Z, Becker RC, Williams R, Kuhn C, Ortel TL, Kuchibhatla M, Prybol K, Rogers J, O'Connor C, Velazquez EJ, Jiang W. Depressive symptoms and mental stress-induced myocardial ischemia in patients with coronary heart disease. Psychosom Med. 2013 Nov-Dec;75(9):822-31. doi: 10.1097/PSY.0b013e3182a893ae. Epub 2013 Oct 25.

  PMID: 24163385 DERIVED

• Jiang W, Velazquez EJ, Kuchibhatla M, Samad Z, Boyle SH, Kuhn C, Becker RC, Ortel TL, Williams RB, Rogers JG, O'Connor C. Effect of escitalopram on mental stress-induced myocardial ischemia: results of the REMIT trial. JAMA. 2013 May 22;309(20):2139-49. doi: 10.1001/jama.2013.5566.

  PMID: 23695483 DERIVED

• Jiang W, Samad Z, Boyle S, Becker RC, Williams R, Kuhn C, Ortel TL, Rogers J, Kuchibhatla M, O'Connor C, Velazquez EJ. Prevalence and clinical characteristics of mental stress-induced myocardial ischemia in patients with coronary heart disease. J Am Coll Cardiol. 2013 Feb 19;61(7):714-22. doi: 10.1016/j.jacc.2012.11.037.

  PMID: 23410543 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Wei Jiang, MD
• Organization: Duke University Medical Center

jiang001@mc.duke.edu

919-668-0762

Study Officials

• Wei Jiang, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 17, 2007
• Study Start: September 1, 2006
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 5, 2015
• Results First Posted: August 5, 2015

Record last verified: 2015-07

Locations

US (1)