Suggestive Effects on the Diameter of Coronary Arteries (SUGO-KO)
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?
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Munich, Tyskland, 81675
- Department of Psychosomatic Medicine, Technische Universität München
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Sodium chloride
Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
|
Experimentell: 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
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
|
Aktiv komparator: Nitroglycerin
Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
|
Experimentell: 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
|
Verbal suggestions of a vasodilatory effect on cardiac vessels
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Stenosis Diameter (Quantitative Coronary Analysis)
Tidsram: 60 sec after intervention
|
60 sec after intervention
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Heart rate
Tidsram: immediately before and after intervention
|
immediately before and after intervention
|
|
Systolic blood pressure
Tidsram: immediately before and after intervention
|
immediately before and after intervention
|
|
Diastolic blood pressure
Tidsram: immediately before and after intervention
|
immediately before and after intervention
|
|
Chest Pain
Tidsram: immediately before and after intervention
|
immediately before and after intervention
|
|
Subjective distress
Tidsram: immediately before and after intervention
|
immediately before and after intervention
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Joram Ronel, M.D., Technical University of Munich
- Huvudutredare: Karin Meißner, M.D., Ludwig-Maximilians-Universität München
- Huvudutredare: Julinda Mehilli, M.D., Deutsches Herzzentrum München
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- SUGOKO
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