Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease

Not Applicable

Completed

• Conditions: Stable Coronary Heart Disease
• Interventions: Dietary Supplement: flavanol-rich drink vs flavanol-free drink

• Registration Number: NCT02520466
• Lead Sponsor: University of Zurich

Brief Summary

The aim of the present study is to investigate whether the ingestion of a cocoa flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and platelet function in patients with overt coronary artery disease acutely (after 2 hours)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-11
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flavanol-containing drink	flavanol-rich drink vs flavanol-free drink	flavanol-containing drink
flavanol-free drink	flavanol-rich drink vs flavanol-free drink	flavanol-free drink matched for taste and calories

Primary Outcome Measures

Name	Time	Method
coronary endothelial function as assessed as response to cold pressor test	2 hours	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.

Trial Locations

Locations (2)

Cardiovascular Center Cardiology Univeristy Hospital of Zurich; 🇨🇭 Zurich, Switzerland

Universisty Hospital of Zurich, Cardiovascular Center Cardiology; 🇨🇭 Zurich, Switzerland