Suggestive Effects on the Diameter of Coronary Arteries
Information source: Technische Universität München
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Circulation
Intervention: Verbal suggestions (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Technische Universität München Official(s) and/or principal investigator(s): Joram Ronel, M.D., Principal Investigator, Affiliation: Technische Universität München Karin Meißner, M.D., Principal Investigator, Affiliation: Ludwig-Maximilians-Universität München Julinda Mehilli, M.D., Principal Investigator, Affiliation: Deutsches Herzzentrum München
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?
Clinical Details
Official title: Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Stenosis Diameter (Quantitative Coronary Analysis)
Secondary outcome: Heart rateSystolic blood pressure Diastolic blood pressure Chest Pain Subjective distress
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Psychosomatic Medicine, Technische Universität München, Munich 81675, Germany
Additional Information
Starting date: July 2008
Last updated: June 19, 2009
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