Mental Stress Ischemia: Biofeedback Study

The purpose of this study is to evaluate the blood flow to the heart during stress and assess
changes in blood flow after psychological treatment in participants with coronary artery
disease. This is a randomized controlled study. The aims of the study are to assess the
effects of heart rate variability (HRV) biofeedback (versus usual care) on global and
regional myocardial blood flow (MBF), peripheral vascular function, and autonomic changes
during mental stress.

All participants will undergo myocardial flow/perfusion imaging with positron emission
tomography (PET) imaging at rest and after a standardized arithmetic mental stress test.
Participants will then undergo repeat testing after 6 weeks. At 12 weeks, participants will
also undergo a limited examination without myocardial perfusion imaging. The intervention
group will receive biofeedback after enrollment, and the wait-list control group will receive
the intervention between week 6 and week 12 study visits (without imaging).

Inclusion Criteria:

Prior participation in the Mental Stress Ischemia: Mechanisms and Prognosis (MIPS) study

Eligibility for the MIPS study included:

- Angiographically proven disease including at least 1 major vessel with evidence of
disease but with no specific minimum lumen diameter criteria

- Prior myocardial ischemia (MI) (>1 months) documented by typical elevation of enzymes
and typical pain or ECG changes

- Abnormal coronary intravascular ultrasound exam (IVUS) demonstrating atherosclerosis
of at least 1 vessel

- Post bypass surgery or post PCI (percutaneous intervention)* (> 1 year after complete
revascularization)

- Positive nuclear scan or stress exercise test

Exclusion Criteria:

- Unstable angina, myocardial infarction, decompensated congestive heart failure in past
week

- Severe concomitant medical problems expected to shorten life expectancy to less than 5
years

- Pregnancy. Women of childbearing age who are not postmenopausal will be screened by
pregnancy test

- Systolic blood pressure >190 mm Hg or diastolic blood pressure >115 mm Hg on the day
of the test

- History of current alcohol or substance abuse or dependence (past year); or history of
severe psychiatric disorder other than major depression, such as schizophrenia or
psychotic depression

- For patients who are unable to exercise, we will do a pharmacological stress test with
regadenoson. Additional exclusion criteria for regadenoson administration include
second- or third-degree AV block (without permanent pacemakers) and bronchospastic
disease such as asthma or severe chronic obstructive lung disease

- Weight more than 450 lbs or a body habitus that is unfit for the nuclear camera
dimensions

- Inflammatory diseases - Rheumatoid Arthritis, Lupus, Hepatitis, HIV, Crohn's, etc.

- Dialysis

- Any malignancy (No active/any metastasis from oncology notes)

- Dementia/Alzheimer's

- Drug incompliance

- No supporting documents for CAD history

- Permanent atrial fibrillation

- Clean vessels after revascularization

- Any transplants

- On any immunosuppressants

- Immobile, in wheel chair (If patient can lift self out of wheel chair then it is okay)