Neurocardiac Interactions Evaluated by Anatomic and Physiologic MRI Assessment

Withdrawn

• Conditions: Stress, Mental; Ischemia
• Interventions: Radiation: Coronary CT Angiography; Other: Mood Symptom Scale; Other: Anxiety Symptom Scale; Other: Chronic Stress Inventories; Other: Psychosocial Function Questionnaires; Other: General Health and quality of life questionnaires; Other: Magnetic Resonance Imaging

• Registration Number: NCT02962154
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The purpose of project is to answer fundamental questions about the mechanisms underlying mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and to identify potential biomarkers and psychosocial risk factors associated with this condition.

To achieve this goal, investigators will use cutting-edge cardiovascular and functional neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory setting in subjects recruited from four patient populations: 1) patients who recently sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease); 3) patients with a diagnosis of major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2 disorder.

Detailed Description

Mental stress ischemia occurs when a psychosocial or mental stressor triggers an imbalance between the supply and demand for oxygen by cardiac myocytes. Epidemiological studies indicate that mental stress ischemia is common, occurring in 20-25% of patients with coronary artery disease (CAD) and portends a poor prognosis. The underlying mechanisms are thought to involve stress-induced activation of the sympathetic nervous system and associated effects on cardiovascular function. But how neurobiological and cardiovascular factors interact to generate mental stress ischemia is unknown. Furthermore, patients with major depressive disorder, bipolar disorder, and other stress-related psychiatric conditions have elevated rates of cardiovascular co-morbidities, including sudden cardiac death, yet mental stress ischemia has not been studied extensively in these psychiatric populations. The purpose of project is to answer fundamental questions about the mechanisms underlying mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and to identify potential biomarkers and psychosocial risk factors associated with this condition.

To achieve this goal, investigators will use cutting-edge cardiovascular and functional neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory setting in subjects recruited from four patient populations: 1) patients who recently sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease); 3) patients with a diagnosis of major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2 disorder.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-04-20
• Study Start: 2016-02
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease (CAD)	Magnetic Resonance Imaging	Patients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Major Depressive Disorder	Magnetic Resonance Imaging	Patients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Coronary Artery Disease (CAD)	Psychosocial Function Questionnaires	Patients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Major Depressive Disorder	Mood Symptom Scale	Patients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Coronary Artery Disease (CAD)	Mood Symptom Scale	Patients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Coronary Artery Disease (CAD)	Chronic Stress Inventories	Patients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Major Depressive Disorder	Coronary CT Angiography	Patients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Major Depressive Disorder	Chronic Stress Inventories	Patients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Major Depressive Disorder	Psychosocial Function Questionnaires	Patients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Coronary Artery Disease (CAD)	Coronary CT Angiography	Patients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Coronary Artery Disease (CAD)	Anxiety Symptom Scale	Patients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Coronary Artery Disease (CAD)	General Health and quality of life questionnaires	Patients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Major Depressive Disorder	Anxiety Symptom Scale	Patients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging
Major Depressive Disorder	General Health and quality of life questionnaires	Patients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging

Primary Outcome Measures

Name	Time	Method
Prevalence of mental stress induced ischemia as measured by cardiac MRI	2 weeks	Subjects will undergo a brief training program for low-stress version of emotion regulation task and working memory task on a laptop. Baseline (non-stress) resting cardiac MR perfusion and baseline (non-stress) brain MRI studies. In addition to a mental stress task brain fMRI and mental stress cardiac MR perfusion. We can analyze the prevalence of mental stress induced ischemia.

Secondary Outcome Measures

Name	Time	Method
Change in cardiac stress perfusion as measured by cardiac MRI (pre and post mental stress)	2 weeks	We will test for within-subject changes in cardiovascular function and neural activity in stress-sensitive brain circuits, comparing pre and post-stress cardiac mRI and brain MRI studies.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States