NCT02962154

Neurocardiac Interactions Evaluated by Anatomic and Physiologic MRI Assessment

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemia
• Stress, Mental

Interventions

Type	Name	Description
RADIATION	Coronary CT Angiography	The coronary CT angiography will assess for coronary artery stenosis, plaque characteristics, calcifications, and other factors.
OTHER	Mood Symptom Scale	Some or all of the following questionnaires will be conducted to assess mood symptoms: Beck Depression Inventory, Hamilton Depression Rating Scale (24-item), Montgomery Asberg Depression Rating Scale (MADRS), Mood and Anxiety Symptom Questionnaire (MASQ), QIDS, Young Mania Rating Scale
OTHER	Anxiety Symptom Scale	Some or all of the following questionnaires will be conducted to assess anxiety symptoms: Beck Anxiety Inventory, Spielberger State/Trait Anxiety Inventory (STAI), GAD-7 Anxiety Questionnaire, Penn State Worry Questionnaire (PSWQ)
OTHER	Chronic Stress Inventories	Some of all of the following questionnaires will be conducted to assess chronic stress: Chronic stress inventories: Cohen Perceived Stress Scale, Holmes and Rahe Stressful Life Events Scale, Karasek Job Strain Questionnaire, Conner-Davidson Resilience Scale, PTSD Checklist
OTHER	Psychosocial Function Questionnaires	Some of all of the following questionnaires will be conducted to assess psychosocial function: Type A Personality Scale, NEO Personality Inventory, Positive and Negative Affect Schedule (PANAS), Behavioral Inhibition/Behavioral Approach Scale (BIS/BAS)
OTHER	General Health and quality of life questionnaires	Some of all of the following questionnaires will be conducted to assess quality of life: EQ-5D Health Questionnaire, Seattle Angina Questionnaire, International Index of Erectile Function (ILEF-5), Pittsburgh Sleep Quality Scale, Morningness Eveningness Questionnaire
OTHER	Magnetic Resonance Imaging	First, subjects will undergo a resting cardiac MR perfusion study to establish baseline (pre-stress) measures of cardiovascular function. Second, subjects will undergo a series of brain magnetic resonance imaging studies (T1-weighted anatomical MRI, diffusion tensor imaging, resting state functional MRI) to establish baseline (pre-stress) measures of brain function and structural correlates. Third, investigators will use a well-validated cognitive task to induce mental stress by testing subjects' working memory for a series of emotionally arousing or neutral images, while repeating the functional MRI scan. Finally, subjects will undergo a repeat cardiac MR perfusion study while being tested on the same mental stress task.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-11-11
• Last updated: 2018-01-09

Locations

1 site across 1 country: United States