Trials / Completed
CompletedNCT00925834
Suggestive Effects on the Diameter of Coronary Arteries
Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Technical University of Munich · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Verbal suggestions | Verbal suggestions of a vasodilatory effect on cardiac vessels |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2009-06-22
- Last updated
- 2009-06-22
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00925834. Inclusion in this directory is not an endorsement.