Suggestive Effects on the Diameter of Coronary Arteries (SUGO-KO)

Technical University of Munich

Status: Completed

Conditions: Coronary Circulation

Treatments: Behavioral: Verbal suggestions

Study type: Interventional

Funder types: Other

Identifiers

NCT00925834

SUGOKO

Details and patient eligibility

About

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?

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Sodium chloride

Placebo Comparator group

Description:

Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride

Treatment:

Behavioral: Verbal suggestions

Sodium chloride and verbal suggestions

Experimental group

Description:

Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels

Treatment:

Behavioral: Verbal suggestions

Nitroglycerin

Active Comparator group

Description:

Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride

Treatment:

Behavioral: Verbal suggestions

Nitroglycerin and verbal suggestions

Experimental group

Description:

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

Treatment:

Behavioral: Verbal suggestions