Responses of Myocardial Ischemia to Escitalopram Treatment - Full Text View

Sponsor:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00574847

Purpose

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.

Condition	Intervention	Phase
Myocardial Ischemia	Drug: Escitalopram Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT Trial)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Depression Heart Diseases Stress

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Escitalopram treatment	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
Placebo Comparator: 2 Placebo	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	21 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574847

Contacts

Contact: Carolyn M Martsberger, PhD

919-668-3647

cmb23@notes.duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Carolyn M Martsberger, PhD 919-668-3647 cmb23@notes.duke.edu
Contact: Jeffrey Cooper 919-681-3217 jeff.cooper@duke.edu
Principal Investigator: Wei Jiang, M.D.

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Wei Jiang, M.D.

Duke University

More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Nov 14.

Responsible Party:	Wei Jiang, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT00574847 History of Changes
Other Study ID Numbers:	8640-07-8R1ER, R01 HL085704-01
Study First Received:	December 12, 2007
Last Updated:	February 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

ischemic heart disease
mental stress-induced myocardial ischemia
escitalopram

Additional relevant MeSH terms:

Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on February 13, 2012