Suggestive Effects on the Diameter of Coronary Arteries
- Conditions
- Coronary Circulation
- Interventions
- Behavioral: Verbal suggestions
- Registration Number
- NCT00925834
- Lead Sponsor
- Technical University of Munich
- Brief Summary
The aim of this randomized controlled pilot study was to answer the following questions:
1. 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?
2. 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?
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- medical indication for heart catheterization
- written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Sodium chloride Verbal suggestions Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride Sodium chloride and verbal suggestions Verbal suggestions Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels Nitroglycerin Verbal suggestions Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride Nitroglycerin and verbal suggestions 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
- Primary Outcome Measures
Name Time Method Stenosis Diameter (Quantitative Coronary Analysis) 60 sec after intervention
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Department of Psychosomatic Medicine, Technische Universität München
🇩🇪Munich, Germany