跳至主要内容
临床试验/NCT00570024
NCT00570024已完成不适用

The Effects of Traditional Acupuncture on Mechanisms of Coronary Heart Disease

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2006年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
2
主要终点
Heart Rate Variability (HRV)

研究概览

简要总结

This research is being done because sudden and unexpected cardiac death remains a significant problem in patients with established coronary heart disease and accounts for 30% of deaths in this group (150,000 deaths annually) despite recognition and treatment of their heart disease. A large body of evidence implicates psychosocial stress as a risk factor and trigger for reduced blood flow in the heart, heart attack and sudden cardiac death, yet the specific mechanisms of this relationship remain under investigation. The nervous system, which plays a role in regulation of the heart, can influence cardiac arrhythmias (irregular heart beats). There are several studies that suggest that acupuncture improves anginal symptoms (like chest pain or tightness) and blood pressure, while reducing stress and improving overall quality of life. The reason that acupuncture seems to have a positive effect on these factors is thought to be that it helps the arteries and the nervous system to work better.

It is possible to measure these effects in a systematic way. The functioning of the artery can be measured by Peripheral Arterial Tonometry, (PAT) a simple monitoring device that measures blood flow using finger probes and a blood pressure cuff. Changes in the nervous system can be measured by using a 24-hour Holter monitor to record the heart rate. The 24-hour Holter monitor will also show if oxygen flow to the heart is decreased, as would happen during stress, by recording a continuous electrocardiogram (ECG). Feelings about stress can be established by questionnaires.

The purpose of this study is to compare three groups of people with known coronary heart disease. One group will receive traditional acupuncture, one group will receive alternative acupuncture, and a third group will receive usual care only.

详细描述

A. SPECIFIC AIMS Sudden and unexpected cardiac death remains a significant problem in patients with established coronary heart disease (CHD), and accounts for 30% of deaths in this group (~150,000 deaths annually) despite recognition and treatment of their disease. These sudden deaths are due to myocardial infarction and ischemic or nonischemically mediated arrythmias. Traditional risk factors do not completely account for the excess of CHD deaths. Although treatment of cardiac risk factors, such as hyperlipidemia, has been shown to significantly reduce cardiac events in populations with established coronary heart disease (e.g. by 34% in the Scandinavian Simvastatin Survival Study1) a majority of patients continue to have sudden and unexpected cardiac events including sudden cardiac death. Indeed, up to 50% of patients with established CHD will have recurrent events despite aggressive management of traditional risk factors such as hyperlipidemia, tobacco use and hypertension. This suggests that additional risk factors or mechanisms participate in the pathophysiological cascade underlying acute CHD events.

A large body of evidence implicates psychosocial stress as a risk factor and trigger for myocardial ischemia, infarction and sudden cardiac death, yet the specific mechanisms(s) of this relationship remain under investigation.2-9 The mechanisms may include hemodynamic, hemostatic and neuronally mediated effects on the cardiovascular system. Specifically they may include a prominent role of the cardiac autonomic nervous system, including the sympathetic nervous system (SNS) and parasympathetic nervous system (PNS).10 Indeed, cardiac arrhythmias have been implicated both as a risk factor and an etiology for sudden cardiac death, suggesting that alteration of cardiac autonomic nervous system tone may provide an opportunity for reducing acute cardiac events and sudden cardiac death. Prior work by ourselves and others has also demonstrated that sympathetic activation from psychosocial stress results in vascular constriction that, in the presence of impaired nitric oxide (NO) production and endothelial dysfunction, contributes to myocardial ischemia and adverse cardiac events, including sudden death. 6,8,11-15 Traditional Acupuncture (TA) is a Complementary and Alternative Medicine (CAM) practice with documented effects of improving physiologic imbalances and reducing psychosocial stress. For example, the TA technique has been shown, to significantly reduce mental stress in humans16, hypertension in an animal model17 and angina pectoris in CHD patients.18 These changes are consistent with the hypothesis that the TA technique directly alters autonomic nervous system tone, likely by reducing SNS activity, and possibly also by increasing PNS activity. We also hypothesize that TA may beneficially alter CHD indirectly by reducing psychosocial stress. Either of these hypotheses suggests that this CAM practice may serve as a complement or alternative to medical treatment for the prevention of acute cardiac events and sudden cardiac death.

We propose to evaluate the effect of TA on arterial vasomotor function and autonomic nervous system tone, two physiologic variables involved in the pathophysiological cascade underlying acute cardiac events and sudden death in CHD patients. To test for both the hypothesized direct and indirect effects of this CAM modality, we propose to compare an active TA intervention to two control groups: 1) an Alternative Acupuncture control group, and 2) a waiting control group, in patients with CHD.

Primary Aim

  1. To assess effects of the TA technique (compared to Alternative Acupuncture and waiting control) on cardiac autonomic nervous system tone, as measured by heart rate variability (HRV) using Holter monitoring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 21 years
  • Male or female
  • Local residence
  • Medically able to participate
  • CAD by MI, CABG, PTCA, or stroke (>3 months prior), or angiographic evidence >50% epicardial coronary artery stenosis in at least one coronary artery
  • Consent and referring MD approval

排除标准

  • Comorbid disease precluding survival during study
  • MI, unstable angina, CABG, PTCA or stroke within 3 months*
  • HIV infection, chronic or active hepatitis or other blood-borne illness
  • Cognitive, psychological or substance abuse-related impairment, as clinically assessed
  • Atrial fibrillation, predominant pacemaker rhythm, significant conduction system disease, or automatic internal defibrillator*
  • Significant valvular heart disease*
  • Class III or IV heart failure*
  • Renal or liver failure, as clinically assessed
  • Participating in TA, or formal psychosocial stress management program
  • Participation in another trial.

研究组 & 干预措施

AA

Other

干预措施: AA (Procedure)

Waiting Group

No Intervention

TA

Active Comparator

Active TA

干预措施: Traditional Acupuncture (Procedure)

结局指标

主要结局

Heart Rate Variability (HRV)

时间窗: 24 hours

Holter monitoring will be recorded during the provocative procedures and during a 24-hour period during which subjects will document their activities and any anginal symptoms in a diary.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noel Bairey Merz

Director

Cedars-Sinai Medical Center

研究点 (2)

Loading locations...

相似试验