Clinical trial NCT00925834: Suggestive Effects on the Diameter of Coronary Arteries
Official title: Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Circulation
Keywords: Coronary angiography
Placebo effect
Suggestion
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: German Heart Center
First posted: 2009-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stenosis Diameter (Quantitative Coronary Analysis)
timeFrame: 60 sec after intervention
Secondary outcomes:
measure: Heart rate
timeFrame: immediately before and after intervention
measure: Systolic blood pressure
timeFrame: immediately before and after intervention
measure: Diastolic blood pressure
timeFrame: immediately before and after intervention
measure: Chest Pain
timeFrame: immediately before and after intervention
measure: Subjective distress
timeFrame: immediately before and after intervention
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Psychosomatic Medicine, Technische Universität München
Study officials:
affiliation: Technical University of Munich
name: Joram Ronel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig-Maximilians-Universität München
name: Karin Meißner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum München
name: Julinda Mehilli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: