Suggestive Effects on the Diameter of Coronary Arteries

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries

Conditions
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Coronary Circulation

Intervention / Treatment
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* Behavioral: Verbal suggestions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sodium chloride<br>Control arm A: Hidden intracoronary infusion of 5ml sodium chloride | Behavioral: Verbal suggestions<br>* Verbal suggestions of a vasodilatory effect on cardiac vessels<br>|
| Experimental: Sodium chloride and verbal suggestions<br>Experimental arm A: Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels | Behavioral: Verbal suggestions<br>* Verbal suggestions of a vasodilatory effect on cardiac vessels<br>|
| Active Comparator: Nitroglycerin<br>Control arm B: Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride | Behavioral: Verbal suggestions<br>* Verbal suggestions of a vasodilatory effect on cardiac vessels<br>|
| Experimental: Nitroglycerin and verbal suggestions<br>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 | Behavioral: Verbal suggestions<br>* Verbal suggestions of a vasodilatory effect on cardiac vessels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stenosis Diameter (Quantitative Coronary Analysis) |  | 60 sec after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary angiography, Placebo effect, Suggestion