Neurocardiac Interactions Evaluated by Anatomic and Physiologic MRI Assessment

NCT02962154 | Withdrawn

• 1 other identifier: 1405015093
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia; Stress, Mental

Keywords

Invasive Coronary Angiography; Myocardial Infarction; Major Depressive Disorder; Bipolar I Disorder; Bipolar II Disorder; Mental Stress

Outcome Measures

Primary Outcomes (1)

• Prevalence of mental stress induced ischemia as measured by cardiac MRI

  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.

  2 weeks

Secondary Outcomes (1)

• Change in cardiac stress perfusion as measured by cardiac MRI (pre and post mental stress)

  2 weeks

Study Arms (2)

Coronary Artery Disease (CAD)

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

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

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

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

Interventions

Coronary CT Angiography RADIATION

The coronary CT angiography will assess for coronary artery stenosis, plaque characteristics, calcifications, and other factors.

Coronary Artery Disease (CAD); Major Depressive Disorder

Mood Symptom Scale OTHER

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

Coronary Artery Disease (CAD); Major Depressive Disorder

Anxiety Symptom Scale OTHER

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)

Coronary Artery Disease (CAD); Major Depressive Disorder

Chronic Stress Inventories OTHER

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

Coronary Artery Disease (CAD); Major Depressive Disorder

Psychosocial Function Questionnaires OTHER

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)

Coronary Artery Disease (CAD); Major Depressive Disorder

General Health and quality of life questionnaires OTHER

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

Coronary Artery Disease (CAD); Major Depressive Disorder

Magnetic Resonance Imaging OTHER

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.

Coronary Artery Disease (CAD); Major Depressive Disorder

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll male and female subjects 50 years of age or older who have: 1. recently sustained a myocardial infarction 2. undergone or are undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease) 3. a diagnosis of major depressive disorder; and a diagnosis of bipolar 1 or bipolar 2 disorder

You may qualify if:

• Male and female subjects, ages 50 years or more
• Able to provide informed consent. Must be fluent english speakers.
• Known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test or invasive coronary angiography (ICA)
• Patients that are hemodynamically stable

You may not qualify if:

• Evidence of ongoing myocardial infarction or homonymic instability
• Positive pregnancy test or unknown pregnant state at the time of enrollment for all women of child-bearing potential
• Known contraindications to cardiovascular CT angiography with intravenous contrast (A) Known allergies (B) Renal dysfunction (GFR \< 30ml/min) (C) Contraindications to beta-blockers or nitroglycerin or adenosine (D) Irregular heart rate not controlled by administration of beta-blockers
• Patients with contraindications to MRI scans (A) Non-MR compatible device or material implant (B) Known allergies to gadolinium containing contrast agent (C) Renal dysfunction (GFR \< 30 ml/min)
• Male and female subjects, ages 50 years or more
• Must be fluent English-speakers due to the design of the mental stress tasks. Able to provide informed consent.
• Subjects who are stable and meet DSM-V criteria for a diagnosis of major depressive disorder, bipolar 1 disorder, or bipolar 2 disorder, as assessed in an initial screening interview by phone and confirmed by a structured clinical interview on the first day of the study.
• Subjects with a history of seizure disorder, stroke, Parkinson's disease, any form of dementia, or head injury resulting in loss of consciousness will be excluded from this study.
• Patients who are currently being treated with a beta blocker or daily (standing) benzodiazepines will be excluded, unless, in the judgment of the prescribing physician, the dose can be withheld on the morning of the each study session, due to the potential for these medications to mask neurobiological and cardiovascular responses to mental stress.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

2mL of blood will be drawn for sample banking for future research studies ONLY from subjects who provide permission for storing their sample for use in future research

MeSH Terms

Conditions

Ischemia; Stress, Psychological; Myocardial Infarction; Depressive Disorder, Major; Bipolar Disorder

Interventions

Health Status; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Necrosis; Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• James K Min, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: November 11, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (1)