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Cardiovascular DiseaseMIBSNCT02657382

Mental Stress Ischemia: Biofeedback Study

A study testing Heart Rate Variability (HRV) Biofeedback (BF) and Mental Stress Protocol in people with Cardiovascular Disease and Coronary Artery Disease, run by Emory University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Heart Rate Variability (HRV) Biofeedback (BF) and Mental Stress Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesUnited States
Study dates
Sep 2015to 24 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Emory University

    Atlanta, Georgia, 30322

  • Rollins School of Public Health

    Atlanta, Georgia, 30322

  • The Emory Clinic

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Effects of Biofeedback on Myocardial Blood Flow Changes During Mental Stress in Patients With Coronary Artery Disease

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.

Read the 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).

Being tested
Heart Rate Variability (HRV) Biofeedback (BF), Mental Stress Protocol
Keywords
Biofeedback, Myocardial Imaging
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart Rate Variability (HRV) Biofeedback (BF)Behavioural

    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 ProtocolOther

    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.

Study groups in NCT02657382
Study groupRoleWhat they receive
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.
Receives: Behavioral: Heart Rate Variability (HRV) Biofeedback (BF); Other: Mental Stress Protocol
Waitlist ControlExperimentalParticipants 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.
Receives: Behavioral: Heart Rate Variability (HRV) Biofeedback (BF); Other: Mental Stress Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 6

  2. 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.

    Measured: Baseline, Week 6

Secondary outcomes (7)

  1. Change in Arterial Compliance assessed by Augmentation Index and Pulse Wave Velocity

    Arterial compliance will be assessed using the SphygmaCor device which is a non-invasive method for assessing the cardiovascular system focused on central blood pressures, measures of arterial stiffness and autonomic function. Peripheral pressure waveforms are recorded from the radial artery at the wrist, using applanation tonometry with a high-fidelity micromanometer. After 20 sequential waveforms have been acquired, a validated generalized transfer function will be used to generate the corresponding central aortic pressure waveform.

    Measured: Baseline, Week 12

  2. Change in Number of Ischemic Regions

    Number of ischemic regions will be measured by PET scan myocardial infusion. Change is defined as the difference in the number of ischemic regions from baseline compared to week six.

    Measured: Baseline, Week 6

  3. Change in Peripheral Arterial Tonometry (PAT) Ratio

    The Peripheral Arterial Tonometry (PAT) reflects the magnitude of change in finger-tip blood flow induced by mental stress by measuring the ratio of pulse wave amplitude during mental stress compared to rest.

    Measured: Baseline, Week 12

  4. Change in Resting Norepinephrine Levels

    Change in resting norepinephrine levels post mental stress test will be evaluated via blood draws obtained at baseline, immediately post mental stress testing, and 90 minutes post mental stress testing. Testing will be completed at all study visits. Change is measured as the difference between resting norepinephrine levels at baseline and post intervention.

    Measured: Baseline, Post Intervention (Up to 12 weeks)

  5. Change in Resting Epinephrine Levels

    Change in resting epinephrine levels post mental stress test will be evaluated via blood draws obtained at baseline, immediately post mental stress testing, and 90 minutes post mental stress testing. Testing will be completed at all study visits. Change is measured as the difference between resting epinephrine levels at baseline and post intervention.

    Measured: Baseline, Post Intervention (Up to 12 weeks)

  6. Change in Resting Dopamine Levels

    Change in resting dopamine levels post mental stress test will be evaluated via blood draws obtained at baseline, immediately post mental stress testing, and 90 minutes post mental stress testing. Testing will be completed at all study visits. Change is measured as the difference between resting dopamine levels at baseline and post intervention.

    Measured: Baseline, Post Intervention (Up to 12 weeks)

  7. Change in Flow-Mediated Dilation (FMD) of the Brachial Artery

    Two-dimensional ultrasound images will be used to assess flow-mediated dilation (FMD) of the brachial artery before and 30 minutes after mental stress testing. Images will be obtained with an Acuson 10 mHz linear array transducer and an Acuson Aspen ultrasound system. Change is measured as the difference in FMD at baseline and week 12.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2016 (estimated)
  2. Study startSep 2015
  3. Primary completion24 Jun 2020
  4. Study completion24 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02657382
Sponsor's protocol ID
IRB00083616
Acronym
MIBS
Status last verified
Sep 2020
First submitted
13 Jan 2016
Last updated
14 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 41118163

  • 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.

    PubMed 31067240

Questions about this trial

What is this clinical trial studying?

A study testing Heart Rate Variability (HRV) Biofeedback (BF) and Mental Stress Protocol in people with Cardiovascular Disease and Coronary Artery Disease, run by Emory University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Global Myocardial Perfusion During Mental Stress (time frame: Baseline, Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02657382, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.

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Mental Stress Ischemia: Biofeedback Study | AzTrials