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

N/ACompletedNCT02520466

University of Zurich37 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Stable Coronary Heart Disease

Interventions

flavanol-rich drink vs flavanol-free drinkDIETARY_SUPPLEMENT

Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Cardiovascular Center Cardiology Univeristy Hospital of Zurich

Zurich, Switzerland

Universisty Hospital of Zurich, Cardiovascular Center Cardiology

Zurich, Switzerland

Outcomes

Primary Outcomes

coronary endothelial function as assessed as response to cold pressor test

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.

Time frame: 2 hours

Data from ClinicalTrials.gov

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