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Mental Stress Ischemia: Biofeedback Study (MIBS)

Primary Purpose

Cardiovascular Disease, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Rate Variability (HRV) Biofeedback (BF)
Mental Stress Protocol
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiovascular Disease focused on measuring Biofeedback, Myocardial Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Emory University Hospital
  • Emory University
  • Rollins School of Public Health
  • The Emory Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Heart Rate Variability (HRV) Biofeedback (BF)

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 13, 2016
Last Updated
September 10, 2020
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02657382
Brief Title
Mental Stress Ischemia: Biofeedback Study
Acronym
MIBS
Official Title
Effects of Biofeedback on Myocardial Blood Flow Changes During Mental Stress in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
June 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Coronary Artery Disease
Keywords
Biofeedback, Myocardial Imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Rate Variability (HRV) Biofeedback (BF)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Heart Rate Variability (HRV) Biofeedback (BF)
Intervention Description
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
Other
Intervention Name(s)
Mental Stress Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Global Myocardial Perfusion During Mental Stress
Description
Global myocardial perfusion during mental stress will be tested via positron emission topography (PET) scan while completing the mental stress protocol.
Time Frame
Baseline, Week 6
Title
Change in Regional Myocardial Perfusion During Mental Stress
Description
Regional myocardial perfusion during mental stress will be tested via positron emission topography (PET) scan while completing the mental stress protocol.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change in Arterial Compliance assessed by Augmentation Index and Pulse Wave Velocity
Description
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.
Time Frame
Baseline, Week 12
Title
Change in Number of Ischemic Regions
Description
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.
Time Frame
Baseline, Week 6
Title
Change in Peripheral Arterial Tonometry (PAT) Ratio
Description
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.
Time Frame
Baseline, Week 12
Title
Change in Resting Norepinephrine Levels
Description
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.
Time Frame
Baseline, Post Intervention (Up to 12 weeks)
Title
Change in Resting Epinephrine Levels
Description
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.
Time Frame
Baseline, Post Intervention (Up to 12 weeks)
Title
Change in Resting Dopamine Levels
Description
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.
Time Frame
Baseline, Post Intervention (Up to 12 weeks)
Title
Change in Flow-Mediated Dilation (FMD) of the Brachial Artery
Description
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.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshed Quyyumi, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rollins School of Public Health
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31067240
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.
Results Reference
derived

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Mental Stress Ischemia: Biofeedback Study

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