Coronary CirculationSUGO-KONCT00925834
Suggestive Effects on the Diameter of Coronary Arteries
A study testing Verbal suggestions in people with Coronary Circulation, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Circulation
- What is being tested?
- Verbal suggestions
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical indication for heart catheterization
- written informed consent
Who cannot join
- acute myocardial infarction
- acute elevation of cardiac enzymes
- regular intake of drugs containing nitroglycerin
- intolerance of nitroglycerin
- hypotension
- renal insufficiency
Show all 12Show fewer
- diabetes mellitus
- hyperthyroidism
- pregnancy
- acute psychiatric disease
- cognitive impairment
- prinzmetal's angina
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychosomatic Medicine, Technische Universität München
Munich, 81675
About this study
Official title: 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:
- 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?
- 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?
Read the 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.
- Conditions
- Coronary Circulation
- Being tested
- Verbal suggestions
- Keywords
- Coronary angiography, Placebo effect, Suggestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal suggestionsBehavioural
Verbal suggestions of a vasodilatory effect on cardiac vessels
| Study group | Role | What they receive |
|---|---|---|
| Sodium chloride | Placebo comparator | Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride Receives: Behavioral: Verbal suggestions |
| Sodium chloride and verbal suggestions | Experimental | Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels Receives: Behavioral: Verbal suggestions |
| Nitroglycerin | Active comparator | Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride Receives: Behavioral: Verbal suggestions |
| Nitroglycerin and verbal suggestions | Experimental | 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 Receives: Behavioral: Verbal suggestions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stenosis Diameter (Quantitative Coronary Analysis)
Measured: 60 sec after intervention
Secondary outcomes (5)
Heart rate
Measured: immediately before and after intervention
Systolic blood pressure
Measured: immediately before and after intervention
Diastolic blood pressure
Measured: immediately before and after intervention
Chest Pain
Measured: immediately before and after intervention
Subjective distress
Measured: immediately before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary CirculationStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, German Heart Center
- Investigators
- Joram Ronel, M.D., Principal investigator, Technical University of MunichKarin Meißner, M.D., Principal investigator, Ludwig-Maximilians-Universität MünchenJulinda Mehilli, M.D., Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925834
- Sponsor's protocol ID
- SUGOKO
- Acronym
- SUGO-KO
- Status last verified
- Jun 2009
- First submitted
- 19 Jun 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries
- ClinicalTrials.gov ID
- NCT00925834
- Acronym / sponsor ID
- SUGO-KO / SUGOKO
- Conditions
- Coronary Circulation
- Keywords
- Coronary angiography, Placebo effect, Suggestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, German Heart Center
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled pilot study was to answer the following questions:
- 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?
- 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?
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride | Placebo comparator | Behavioral: Verbal suggestionsControl arm "A": Hidden intracoronary infusion of 5ml sodium chloride |
| Sodium chloride and verbal suggestions | Experimental | Behavioral: Verbal suggestionsExperimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels |
| Nitroglycerin | Active comparator | Behavioral: Verbal suggestionsControl arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride |
| Nitroglycerin and verbal suggestions | Experimental | Behavioral: Verbal suggestionsControl 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- medical indication for heart catheterization
- written informed consent
Key exclusion criteria (12 listed)
- acute myocardial infarction
- acute elevation of cardiac enzymes
- regular intake of drugs containing nitroglycerin
- intolerance of nitroglycerin
- hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal suggestionsVerbal suggestions of a vasodilatory effect on cardiac vessels | Behavioural | Nitroglycerin, Nitroglycerin and verbal suggestions, Sodium chloride, Sodium chloride and verbal suggestions |
Primary outcome
Stenosis Diameter (Quantitative Coronary Analysis)
Time frame: 60 sec after intervention
5 secondary outcomes
Heart rate
Time frame: immediately before and after intervention
Systolic blood pressure
Time frame: immediately before and after intervention
Diastolic blood pressure
Time frame: immediately before and after intervention
Chest Pain
Time frame: immediately before and after intervention
Subjective distress
Time frame: immediately before and after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joram Ronel, M.D. principal investigator
Technical University of Munich
Karin Meißner, M.D. principal investigator
Ludwig-Maximilians-Universität München
Julinda Mehilli, M.D. principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal suggestions in people with Coronary Circulation, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stenosis Diameter (Quantitative Coronary Analysis) (time frame: 60 sec after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2009.