Stable Coronary Heart Disease
Conditions
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)
Interventions
DIETARY_SUPPLEMENTflavanol-rich drink vs flavanol-free drink
Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Outcome results
None listed