Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Stenosis Diameter (Quantitative Coronary Analysis)
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medical indication for heart catheterization
- •written informed consent
排除标准
- •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
结局指标
主要结局
Stenosis Diameter (Quantitative Coronary Analysis)
时间窗: 60 sec after intervention
次要结局
- Diastolic blood pressure(immediately before and after intervention)
- Chest Pain(immediately before and after intervention)
- Subjective distress(immediately before and after intervention)
- Heart rate(immediately before and after intervention)
- Systolic blood pressure(immediately before and after intervention)