Clinical trial NCT02657382: Mental Stress Ischemia: Biofeedback Study
Official title: Effects of Biofeedback on Myocardial Blood Flow Changes During Mental Stress in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Coronary Artery Disease
Keywords: Biofeedback
Myocardial Imaging
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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. 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.

Detailed description: 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Global Myocardial Perfusion During Mental Stress
timeFrame: Baseline, Week 6
measure: Change in Regional Myocardial Perfusion During Mental Stress
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change in Arterial Compliance assessed by Augmentation Index and Pulse Wave Velocity
timeFrame: Baseline, Week 12
measure: Change in Number of Ischemic Regions
timeFrame: Baseline, Week 6
measure: Change in Peripheral Arterial Tonometry (PAT) Ratio
timeFrame: Baseline, Week 12
measure: Change in Resting Norepinephrine Levels
timeFrame: Baseline, Post Intervention (Up to 12 weeks)
measure: Change in Resting Epinephrine Levels
timeFrame: Baseline, Post Intervention (Up to 12 weeks)
measure: Change in Resting Dopamine Levels
timeFrame: Baseline, Post Intervention (Up to 12 weeks)
measure: Change in Flow-Mediated Dilation (FMD) of the Brachial Artery
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Rollins School of Public Health
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Arshed Quyyumi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gurel NZ, Carek AM, Inan OT, Levantsevych O, Abdelhadi N, Hammadah M, O'Neal WT, Kelli H, Wilmot K, Ward L, Rhodes S, Pearce BD, Mehta PK, Kutner M, Garcia E, Quyyumi A, Vaccarino V, Raggi P, Bremner JD, Shah AJ. Comparison of autonomic stress reactivity in young healthy versus aging subjects with heart disease. PLoS One. 2019 May 8;14(5):e0216278. doi: 10.1371/journal.pone.0216278. eCollection 2019.