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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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 1, 2015
Primary Completion Date
June 24, 2020
Completion Date
June 24, 2020
Last Updated
September 14, 2020
25
ACTUAL participants
Heart Rate Variability (HRV) Biofeedback (BF)
BEHAVIORAL
Mental Stress Protocol
OTHER
Lead Sponsor
Emory University
NCT03372733
NCT07241390
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06909773