Coronary Circulation
Conditions
Keywords
Coronary angiography, Placebo effect, Suggestion
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.
Interventions
BEHAVIORALVerbal suggestions
Verbal suggestions of a vasodilatory effect on cardiac vessels
Sponsors
Ludwig-Maximilians - University of Munich
German Heart Center
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stenosis Diameter (Quantitative Coronary Analysis) | 60 sec after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate | immediately before and after intervention |
| Systolic blood pressure | immediately before and after intervention |
| Diastolic blood pressure | immediately before and after intervention |
| Chest Pain | immediately before and after intervention |
| Subjective distress | immediately before and after intervention |
Countries
Germany
Outcome results
None listed