Neurocardiac Interactions Evaluated by Anatomic and Physiologic MRI Assessment

NCT02962154 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-01-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • James K Min, MD · Weill Medical College of Cornell University

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02962154 on ClinicalTrials.gov