Suggestive Effects on the Diameter of Coronary Arteries (SUGO-KO)
Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries
The aim of this randomized controlled pilot study was to answer the following questions:
- Is it possible to affect the diameter of coronary arteries through a placebo injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?
- Is it possible to affect the diameter of coronary arteries through a pharmacologically underdosed nitroglycerine injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?
研究概览
详细说明
The present study is a randomized controlled double-blind single center study in order to investigate the effects of verbal suggestions ('vasodilatation') in combination with either a placebo-intervention (sodium chloride 0.9%) or an underdosed vasodilating medication (nitroglycerine) on the diameter of coronary arteries. 60 patients with a clinical indication to undergo a coronary angiogram were recruited in the German Heart Centre Munich. Patients with acute myocardial events and the necessity for coronary intervention were excluded from the study. Patients were randomized into one of four arms of the two experiments:
Experiment A: Intracoronary (i.c.) placebo-infusion together with a standardized verbal suggestion of coronary vasodilation vs. i.c. placebo-infusion without verbal suggestion.
Experiment B: i.c. infusion of a very low dosed nitroglycerin together with a standardized verbal suggestion of coronary vasodilation vs. i.c. nitroglycerine infusion without verbal suggestion.
To our best knowledge this study is the first to investigate the modulating effects of verbal suggestions going along with medical interventions on the diameter of coronary arteries during heart catheterization.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Munich、德国、81675
- Department of Psychosomatic Medicine, Technische Universität München
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- medical indication for heart catheterization
- written informed consent
Exclusion Criteria:
- acute myocardial infarction
- acute elevation of cardiac enzymes
- regular intake of drugs containing nitroglycerin
- intolerance of nitroglycerin
- hypotension
- renal insufficiency
- diabetes mellitus
- hyperthyroidism
- pregnancy
- acute psychiatric disease
- cognitive impairment
- prinzmetal's angina
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:Sodium chloride
Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
|
实验性的:Sodium chloride and verbal suggestions
Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels
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Verbal suggestions of a vasodilatory effect on cardiac vessels
|
|
有源比较器:Nitroglycerin
Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
|
实验性的:Nitroglycerin and verbal suggestions
Control arm "B": Open intracoronary infusion of 0.01 mg nitroglycerin in 5 ml sodium chloride plus the suggestion of a vasodilatory effect on cardiac vessels
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Stenosis Diameter (Quantitative Coronary Analysis)
大体时间:60 sec after intervention
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60 sec after intervention
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Heart rate
大体时间:immediately before and after intervention
|
immediately before and after intervention
|
|
Systolic blood pressure
大体时间:immediately before and after intervention
|
immediately before and after intervention
|
|
Diastolic blood pressure
大体时间:immediately before and after intervention
|
immediately before and after intervention
|
|
Chest Pain
大体时间:immediately before and after intervention
|
immediately before and after intervention
|
|
Subjective distress
大体时间:immediately before and after intervention
|
immediately before and after intervention
|
合作者和调查者
调查人员
- 首席研究员:Joram Ronel, M.D.、Technical University of Munich
- 首席研究员:Karin Meißner, M.D.、Ludwig-Maximilians-Universität München
- 首席研究员:Julinda Mehilli, M.D.、Deutsches Herzzentrum München
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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