Mental Stress Ischemia: Biofeedback Study

NCT ID: NCT02657382

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-06-24

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).

Conditions

Cardiovascular Disease; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Heart Rate Variability (HRV) Biofeedback (BF)

Participants with coronary artery disease randomized to this group will complete myocardial blood flow (MBF) imaging and mental stress tests. Participants in this group will also participate in heart rate variability (HRV) biofeedback (BF) during the first six weeks of the study.

Group Type: EXPERIMENTAL

Heart Rate Variability (HRV) Biofeedback (BF)

Intervention Type: BEHAVIORAL

Heart Rate Variability (HRV) biofeedback involves deep breathing, mindfulness (focusing on one's emotions and thoughts) and cognitive therapy (identifying and changing unhelpful or inaccurate thinking and distressing emotional responses). It is a 6-week training with one hour sessions with a certified biofeedback coach once per week. A handheld personal stress reliever device will be provided to the patients to practice at home for 20 minutes a day.

Mental Stress Protocol

Intervention Type: OTHER

Mental stress will consist of a 3-min math serial subtraction paradigm.The participants will be asked to serially subtract 7 from number specified by the researcher. For participants who have difficulty with this task, easier serial subtraction will be provided for. Throughout the task, to increase stressfulness and titrate difficulty, the participant will be prompted for faster performance and the starting number from which they were subtracting will be periodically changed. Finally, to add an evaluation component, participants will be given negative feedback during the test.

Waitlist Control

Participants with coronary artery disease randomized to this group will complete myocardial blood flow (MBF) imaging and mental stress tests.Participants in this group will receive the heart rate variability (HRV) biofeedback (BF) intervention between the week 6 and week 12 study visits.

Group Type: EXPERIMENTAL

Heart Rate Variability (HRV) Biofeedback (BF)

Intervention Type: BEHAVIORAL

Heart Rate Variability (HRV) biofeedback involves deep breathing, mindfulness (focusing on one's emotions and thoughts) and cognitive therapy (identifying and changing unhelpful or inaccurate thinking and distressing emotional responses). It is a 6-week training with one hour sessions with a certified biofeedback coach once per week. A handheld personal stress reliever device will be provided to the patients to practice at home for 20 minutes a day.

Mental Stress Protocol

Intervention Type: OTHER

Mental stress will consist of a 3-min math serial subtraction paradigm.The participants will be asked to serially subtract 7 from number specified by the researcher. For participants who have difficulty with this task, easier serial subtraction will be provided for. Throughout the task, to increase stressfulness and titrate difficulty, the participant will be prompted for faster performance and the starting number from which they were subtracting will be periodically changed. Finally, to add an evaluation component, participants will be given negative feedback during the test.

Interventions

Heart Rate Variability (HRV) Biofeedback (BF)

Heart Rate Variability (HRV) biofeedback involves deep breathing, mindfulness (focusing on one's emotions and thoughts) and cognitive therapy (identifying and changing unhelpful or inaccurate thinking and distressing emotional responses). It is a 6-week training with one hour sessions with a certified biofeedback coach once per week. A handheld personal stress reliever device will be provided to the patients to practice at home for 20 minutes a day.

Intervention Type: BEHAVIORAL

Mental Stress Protocol

Mental stress will consist of a 3-min math serial subtraction paradigm.The participants will be asked to serially subtract 7 from number specified by the researcher. For participants who have difficulty with this task, easier serial subtraction will be provided for. Throughout the task, to increase stressfulness and titrate difficulty, the participant will be prompted for faster performance and the starting number from which they were subtracting will be periodically changed. Finally, to add an evaluation component, participants will be given negative feedback during the test.

Intervention Type: OTHER

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
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Arshed A. Quyyumi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arshed Quyyumi, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Rollins School of Public Health

Atlanta, Georgia, United States

The Emory Clinic

Atlanta, Georgia, United States

Countries

United States

References

Shah AJ, Raggi P, She H, Quyyumi AA, Levantsevych O, Johnson M, Schmidt K, Garcia E, Piccinelli M, Abdulbaki R, Abdelhadi N, Kaseer B, Ginsberg JP, Vaccarino V, Bremner JD. Heart Rate Variability Biofeedback and Mental Stress Myocardial Flow Reserve: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538416. doi: 10.1001/jamanetworkopen.2025.38416.

Reference Type: DERIVED

PMID: 41118163 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31067240 (View on PubMed)

Other Identifiers

IRB00083616

Identifier Type: -

Identifier Source: org_study_id