- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02520466
Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease
Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Zurich, Schweiz
- Cardiovascular Center Cardiology Univeristy Hospital of Zurich
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Zurich, Schweiz
- Universisty Hospital of Zurich, Cardiovascular Center Cardiology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention
- Age 20 - 80
- Written obtained informed consent
Exclusion Criteria:
- Acute ST-elevation myocardial infarction
- Acute non-ST-elevation myocardial infarction (enzyme positive)
- Ventricular tachy-arrythmias or AV-Block >I°
- Renal insufficiency (GFR MDRD < 30ml/min) or liver disease (ALT or AST >150 IU)
- Pregnancy
- Known allergy to compounds of cocoa product
- Known allergy to contrast media
- Known allergy to nuts
- Intolerance to coffein and theobromin
- Acute infectious disease
- Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- Participation in another study within the last month
- Concomitant vitamin supplements and herbal remedies, as well as fruit and tea extracts
- No study visits ± 1 week before Eastern, Christmas and New Year holyday (altered eating habits)
- Extreme eating habits (as assessed by a questionnaire)
- Alcohol or drug abuse
- Lactose intolerance
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: flavanol-containing drink
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Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content
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Placebo komparator: flavanol-free drink
flavanol-free drink matched for taste and calories
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Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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coronary endothelial function as assessed as response to cold pressor test
Tidsramme: 2 hours
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Primary endpoint will be the improvement in coronary endothelial function in response to cold pressor testing (i.e. % reduction in coronary artery constriction compared to baseline) 2h after ingestion of a cocoa flavanol rich-drink or placebo drink, respectively. In a subset of patients daily consumption of a flavanol-drink will be assessed and outcomes measured after 3-4 weeks. |
2 hours
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Thomas F Lüscher, Prof MD, University Hospital Zurich, Cardiovascular Center Cardiology
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EK2012-0201
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Kliniske forsøg med flavanol-rich drink vs flavanol-free drink
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University of California, DavisMars, Inc.AfsluttetSund og raskForenede Stater