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Mental Stress Ischemia: Biofeedback Study (MIBS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Emory University
Sponsor:
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier:
NCT02657382
First received: January 13, 2016
Last updated: October 31, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Cardiovascular Disease
Coronary Artery Disease
Behavioral: Heart Rate Variability (HRV) Biofeedback (BF)
Other: Mental Stress Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effects of Biofeedback on Myocardial Blood Flow Changes During Mental Stress in Patients With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Change in Global Myocardial Perfusion During Mental Stress [ Time Frame: Baseline, Week 6 ]
    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 [ Time Frame: Baseline, Week 6 ]
    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 [ Time Frame: Baseline, Week 12 ]
    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 [ Time Frame: Baseline, Week 6 ]
    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 [ Time Frame: Baseline, Week 12 ]
    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 [ Time Frame: Baseline, Post Intervention (Up to 12 weeks) ]
    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 [ Time Frame: Baseline, Post Intervention (Up to 12 weeks) ]
    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 [ Time Frame: Baseline, Post Intervention (Up to 12 weeks) ]
    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 [ Time Frame: Baseline, Week 12 ]
    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.


Estimated Enrollment: 34
Study Start Date: September 2015
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
Other: 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.
Experimental: 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.
Behavioral: 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.
Other: 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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02657382

Contacts
Contact: Lucy Shallenberger 404-712-8267 lshalle@emory.edu

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lucy Shallenberger    404-712-8267    lshalle@emory.edu   
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lucy Shallenberger    404-712-9569    lshalle@emory.edu   
Rollins School of Public Health Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lucy Shallenberger    404-712-8267    lshalle@emory.edu   
The Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lucy Shallenberger    404-712-8267    lshalle@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Arshed Quyyumi, MD Emory University
  More Information

Responsible Party: Arshed A. Quyyumi, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02657382     History of Changes
Other Study ID Numbers: IRB00083616
Study First Received: January 13, 2016
Last Updated: October 31, 2016

Keywords provided by Emory University:
Biofeedback
Myocardial Imaging

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Stress, Psychological
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 24, 2017