Suggestive Effects on the Diameter of Coronary Arteries

Coronary Circulation Clinical Trial

— SUGO-KO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925834
• Other study ID #: SUGOKO
• Status: Completed
• Phase: N/A
• First received: June 19, 2009
• Last updated: June 19, 2009
• Start date: July 2008
• Est. completion date: August 2008

Study information

• Verified date: June 2009
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Circulation

Intervention

Behavioral:
• Verbal suggestions
Verbal suggestions of a vasodilatory effect on cardiac vessels

Locations

Country	Name	City	State
Germany	Department of Psychosomatic Medicine, Technische Universität München	Munich

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität München	German Heart Center, Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stenosis Diameter (Quantitative Coronary Analysis)		60 sec after intervention	No
Secondary	Heart rate		immediately before and after intervention	No
Secondary	Systolic blood pressure		immediately before and after intervention	No
Secondary	Diastolic blood pressure		immediately before and after intervention	No
Secondary	Chest Pain		immediately before and after intervention	No
Secondary	Subjective distress		immediately before and after intervention	No