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Completed

NCT Number: NCT00925834

Suggestive Effects on the Diameter of Coronary Arteries

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?

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychosomatic Medicine, Technische Universität München

Munich, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verbal suggestions

Behavioral

Verbal suggestions of a vasodilatory effect on cardiac vessels

Primary outcomes

  1. Stenosis Diameter (Quantitative Coronary Analysis)

    Time frame: 60 sec after intervention

Secondary outcomes

  1. Heart rate

    Time frame: immediately before and after intervention

  2. Systolic blood pressure

    Time frame: immediately before and after intervention

  3. Diastolic blood pressure

    Time frame: immediately before and after intervention

  4. Chest Pain

    Time frame: immediately before and after intervention

  5. Subjective distress

    Time frame: immediately before and after intervention

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • German Heart Center
  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

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

Acronym: SUGO-KO

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 22, 2009
Registry last updated
Jun 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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