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

Study Overview
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Brief Summary
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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)

Official Title
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Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease

Conditions
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Stable Coronary Heart Disease

Intervention / Treatment
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* Dietary Supplement: flavanol-rich drink vs flavanol-free drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flavanol-containing drink<br>flavanol-containing drink | Dietary Supplement: flavanol-rich drink vs flavanol-free drink<br>* Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content<br>|
| Placebo Comparator: flavanol-free drink<br>flavanol-free drink matched for taste and calories | Dietary Supplement: flavanol-rich drink vs flavanol-free drink<br>* Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours |