Mental Stress Ischemia: Biofeedback Study
MIBS
Effects of Biofeedback on Myocardial Blood Flow Changes During Mental Stress in Patients With Coronary Artery Disease
1 other identifier
interventional
25
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2020
CompletedSeptember 14, 2020
September 1, 2020
4.8 years
January 13, 2016
September 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Global Myocardial Perfusion During Mental Stress
Global myocardial perfusion during mental stress will be tested via positron emission topography (PET) scan while completing the mental stress protocol.
Baseline, Week 6
Change in Regional Myocardial Perfusion During Mental Stress
Regional myocardial perfusion during mental stress will be tested via positron emission topography (PET) scan while completing the mental stress protocol.
Baseline, Week 6
Secondary Outcomes (7)
Change in Arterial Compliance assessed by Augmentation Index and Pulse Wave Velocity
Baseline, Week 12
Change in Number of Ischemic Regions
Baseline, Week 6
Change in Peripheral Arterial Tonometry (PAT) Ratio
Baseline, Week 12
Change in Resting Norepinephrine Levels
Baseline, Post Intervention (Up to 12 weeks)
Change in Resting Epinephrine Levels
Baseline, Post Intervention (Up to 12 weeks)
- +2 more secondary outcomes
Study Arms (2)
Heart Rate Variability (HRV) Biofeedback (BF)
EXPERIMENTALParticipants 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.
Waitlist Control
EXPERIMENTALParticipants 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (4)
Emory University Hospital
Atlanta, Georgia, 30322, United States
Emory University
Atlanta, Georgia, 30322, United States
Rollins School of Public Health
Atlanta, Georgia, 30322, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Related Publications (2)
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.
PMID: 41118163DERIVEDGurel 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.
PMID: 31067240DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arshed Quyyumi, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 13, 2016
First Posted
January 15, 2016
Study Start
September 1, 2015
Primary Completion
June 24, 2020
Study Completion
June 24, 2020
Last Updated
September 14, 2020
Record last verified: 2020-09