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

This study has been completed.
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
German Heart Center
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00925834
First received: June 19, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention
Coronary Circulation
Behavioral: Verbal suggestions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Stenosis Diameter (Quantitative Coronary Analysis) [ Time Frame: 60 sec after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: immediately before and after intervention ] [ Designated as safety issue: No ]
  • Systolic blood pressure [ Time Frame: immediately before and after intervention ] [ Designated as safety issue: No ]
  • Diastolic blood pressure [ Time Frame: immediately before and after intervention ] [ Designated as safety issue: No ]
  • Chest Pain [ Time Frame: immediately before and after intervention ] [ Designated as safety issue: No ]
  • Subjective distress [ Time Frame: immediately before and after intervention ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Joram Ronel, Dr. Karin Meissner, Technische Universität München
ClinicalTrials.gov Identifier: NCT00925834     History of Changes
Other Study ID Numbers: SUGOKO
Study First Received: June 19, 2009
Last Updated: June 19, 2009
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014