Neurocardiac Interactions Evaluated by Anatomic and Physiologic MRI Assessment

Withdrawn

• Conditions: Stress, Mental; Ischemia

• 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.

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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