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Suggestive Effects on the Diameter of Coronary Arteries

Information source: Technische Universitšt MŁnchen
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 Universitšt MŁnchen

Official(s) and/or principal investigator(s):
Joram Ronel, M.D., Principal Investigator, Affiliation: Technische Universit√§t M√ľnchen
Karin Mei√üner, M.D., Principal Investigator, Affiliation: Ludwig-Maximilians-Universit√§t M√ľnchen
Julinda Mehilli, M.D., Principal Investigator, Affiliation: Deutsches Herzzentrum M√ľnchen

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 rate

Systolic 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 Universit√§t M√ľnchen, Munich 81675, Germany
Additional Information

Starting date: July 2008
Last updated: June 19, 2009

Page last updated: August 23, 2015

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