Effect of Heartfulness meditation practices on endothelial function and inflammation in patients with coronary artery disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of heartfulness meditation practices for four months compared to baseline (before start of intervention) on
研究概览
简要总结
This is a prospective, interventional, single group study with pre-test – post-test design to study the effect of Heartfulness meditation practices on endothelial function and inflammation in patients with coronary artery disease. The study will be conducted in a single centre - Department of Cardiology, Sri Venkateswara Institute of Medical Sciences, Andhra Pradesh. All the patients enrolled in the study will be trained for 3 consecutive days by a certified trainer on heartfulness meditation practices – meditation, cleaning and prayer and will be asked to practice them daily for a period of four months. The primary outcome measures will be changes in brachial artery reactivity to flow mediated dilatation, blood levels of inflammatory markers – hsCRP and IL-6, and gene expression of IL-6 gene. Secondary outcome measures will be changes in quality of life (QOL) and selected wellbeing parameters using questionnaires – WHOQOL BREF (WHO Quality of Life Brief questionnaire), Mental Health Continuum Short Form (MHC-SF), Depression, Anxiety & Stress Scale (DASS 21), and changes in carotid intimal medial thickness & carotid plaque score by carotid Doppler.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA: All patients of either sex with age >30 years and < 65 years with documented evidence of significant and stable coronary artery disease who:
- •Did not undergone percutaneous coronary revascularization
- •Did not undergone coronary artery bypass grafting (CABG)
- •Are willing to participate in the study.
排除标准
- •EXCLUSION CRITERIA:
- •Patients who had already undergone percutaneous coronary revascularization or CABG
- •Patients with acute coronary syndrome.
- •Patients with significant left main coronary artery stenosis.
- •Patients with ejection fraction < 40%.
- •Patients with moderate to severe ischaemic mitral regurgitation.
- •Patients with moderate to severe pulmonary arterial hypertension
- •Patients with structural heart disease
- •Patients with decompensated heart failure
- •Patients with renal impairment
- •Patients with known malignancies
- •Pregnant women
- •Patients already practicing any form of meditation
- •Patients not willing to participate in the study.
结局指标
主要结局
Effect of heartfulness meditation practices for four months compared to baseline (before start of intervention) on
时间窗: At baseline (before intervention) and at four months after intervention
1. Change in brachial artery reactivity to flow mediated dilatation
时间窗: At baseline (before intervention) and at four months after intervention
2. Change in blood levels of inflammatory markers - hsCRP and IL-6
时间窗: At baseline (before intervention) and at four months after intervention
3. Change in gene expression of IL-6 gene
时间窗: At baseline (before intervention) and at four months after intervention
次要结局
- Effect of heartfulness meditation practices for four months compared to baseline (before start of intervention) on(1. Change in quality of life (QOL) and selected wellbeing parameters using questionnaires – WHOQOL BREF (WHO Quality Of Life Brief questionnaire), Mental Health Continuum Short Form (MHC-SF), Depression, Anxiety & Stress Scale (DASS 21).)