- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00925834
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?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Munich, Tyskland, 81675
- Department of Psychosomatic Medicine, Technische Universität München
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Sodium chloride
Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride
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Verbal suggestions of a vasodilatory effect on cardiac vessels
|
Eksperimentell: 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
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Verbal suggestions of a vasodilatory effect on cardiac vessels
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Aktiv komparator: Nitroglycerin
Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride
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Verbal suggestions of a vasodilatory effect on cardiac vessels
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Eksperimentell: 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
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Verbal suggestions of a vasodilatory effect on cardiac vessels
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Stenosis Diameter (Quantitative Coronary Analysis)
Tidsramme: 60 sec after intervention
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60 sec after intervention
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Heart rate
Tidsramme: immediately before and after intervention
|
immediately before and after intervention
|
Systolic blood pressure
Tidsramme: immediately before and after intervention
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immediately before and after intervention
|
Diastolic blood pressure
Tidsramme: immediately before and after intervention
|
immediately before and after intervention
|
Chest Pain
Tidsramme: immediately before and after intervention
|
immediately before and after intervention
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Subjective distress
Tidsramme: immediately before and after intervention
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immediately before and after intervention
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Joram Ronel, M.D., Technical University of Munich
- Hovedetterforsker: Karin Meißner, M.D., Ludwig-Maximilians-Universität München
- Hovedetterforsker: Julinda Mehilli, M.D., Deutsches Herzzentrum München
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- SUGOKO
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