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

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ClinicalTrials.gov Identifier: NCT00925834
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : June 22, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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?

Condition or disease Intervention/treatment
Coronary Circulation Behavioral: Verbal suggestions

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries
Study Start Date : July 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Sodium chloride
Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride
Behavioral: Verbal suggestions
Verbal suggestions of a vasodilatory effect on cardiac vessels
Experimental: Sodium chloride and verbal suggestions
Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels
Behavioral: Verbal suggestions
Verbal suggestions of a vasodilatory effect on cardiac vessels
Active Comparator: Nitroglycerin
Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride
Behavioral: Verbal suggestions
Verbal suggestions of a vasodilatory effect on cardiac vessels
Experimental: Nitroglycerin and verbal suggestions
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
Behavioral: Verbal suggestions
Verbal suggestions of a vasodilatory effect on cardiac vessels


Outcome Measures

Primary Outcome Measures :
  1. Stenosis Diameter (Quantitative Coronary Analysis) [ Time Frame: 60 sec after intervention ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925834


Locations
Germany
Department of Psychosomatic Medicine, Technische Universität München
Munich, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Ludwig-Maximilians - University of Munich
German Heart Center
Investigators
Principal Investigator: Joram Ronel, M.D. Technische Universität München
Principal Investigator: Karin Meißner, M.D. Ludwig-Maximilians-Universität München
Principal Investigator: Julinda Mehilli, M.D. Deutsches Herzzentrum München
More Information

Responsible Party: Dr. Joram Ronel, Dr. Karin Meissner, Technische Universität München
ClinicalTrials.gov Identifier: NCT00925834     History of Changes
Other Study ID Numbers: SUGOKO
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009

Keywords provided by Technische Universität München:
Coronary angiography
Placebo effect
Suggestion

Additional relevant MeSH terms:
Nitroglycerin
Vasodilator Agents