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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| German Heart Center | OTHER |
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The aim of this randomized controlled pilot study was to answer the following questions:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium chloride | Placebo Comparator | Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride |
|
| Sodium chloride and verbal suggestions | Experimental | Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels |
|
| Nitroglycerin | Active Comparator | Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride |
|
| Nitroglycerin and verbal suggestions | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verbal suggestions | Behavioral | Verbal suggestions of a vasodilatory effect on cardiac vessels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stenosis Diameter (Quantitative Coronary Analysis) | 60 sec after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | immediately before and after intervention | |
| Systolic blood pressure | immediately before and after intervention | |
| Diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joram Ronel, M.D. | Technical University of Munich | Principal Investigator |
| Karin Meißner, M.D. | Ludwig-Maximilians-Universität München | Principal Investigator |
| Julinda Mehilli, M.D. | Deutsches Herzzentrum München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychosomatic Medicine, Technische Universität München | Munich | 81675 | Germany |
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| immediately before and after intervention |
| Chest Pain | immediately before and after intervention |
| Subjective distress | immediately before and after intervention |