Neurocardiac Interactions Evaluated by Anatomic and Physiologic MRI Assessment

(NIRVANA Trial)

Overseen by James K Min, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

James K Min, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

Inclusion Criteria

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)

Treatment Details

Interventions

• Anxiety Symptom Scale (Other)
• Chronic Stress Inventories (Other)
• Coronary CT Angiography (Procedure)
• General Health and quality of life questionnaires (Other)
• Magnetic Resonance Imaging (Other)
• Mood Symptom Scale (Other)
• Psychosocial Function Questionnaires (Other)

Participant Groups

Group I: Major Depressive Disorder Experimental Treatment 7 Interventions

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

Group II: Coronary Artery Disease (CAD) Experimental Treatment 7 Interventions

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

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+