Effects of Biofeedback on Myocardial Blood Flow Changes During Mental Stress in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Change in Regional Myocardial Perfusion During Mental Stress
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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)
结局指标
主要结局
Change in Regional Myocardial Perfusion During Mental Stress
时间窗: Baseline, Week 6
Regional myocardial perfusion during mental stress will be tested via positron emission topography (PET) scan while completing the mental stress protocol.
Change in Global Myocardial Perfusion During Mental Stress
时间窗: Baseline, Week 6
Global myocardial perfusion during mental stress will be tested via positron emission topography (PET) scan while completing the mental stress protocol.
次要结局
- 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 Resting Epinephrine Levels(Baseline, Post Intervention (Up to 12 weeks))
- Change in Flow-Mediated Dilation (FMD) of the Brachial Artery(Baseline, Week 12)
- Change in Peripheral Arterial Tonometry (PAT) Ratio(Baseline, Week 12)
- Change in Resting Dopamine Levels(Baseline, Post Intervention (Up to 12 weeks))
- Change in Resting Norepinephrine Levels(Baseline, Post Intervention (Up to 12 weeks))
研究者
Arshed A. Quyyumi
Professor
Emory University