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

June 19, 2009 updated by: Technical University of Munich

Effects of Suggestive Components of Therapeutical Interventions 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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81675
        • Department of Psychosomatic Medicine, Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stenosis Diameter (Quantitative Coronary Analysis)
Time Frame: 60 sec after intervention
60 sec after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate
Time Frame: immediately before and after intervention
immediately before and after intervention
Systolic blood pressure
Time Frame: immediately before and after intervention
immediately before and after intervention
Diastolic blood pressure
Time Frame: immediately before and after intervention
immediately before and after intervention
Chest Pain
Time Frame: immediately before and after intervention
immediately before and after intervention
Subjective distress
Time Frame: immediately before and after intervention
immediately before and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Ludwig-Maximilians - University of Munich
German Heart Center

Investigators

  • Principal Investigator: Joram Ronel, M.D., Technical University of Munich
  • Principal Investigator: Karin Meißner, M.D., Ludwig-Maximilians-Universität München
  • Principal Investigator: Julinda Mehilli, M.D., Deutsches Herzzentrum München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2009

Last Update Submitted That Met QC Criteria

June 19, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SUGOKO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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