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

Stable Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520466
• Other study ID #: EK2012-0201
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Coronary Heart Disease

Intervention

Dietary Supplement:
• flavanol-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

Locations

Country	Name	City	State
Switzerland	Cardiovascular Center Cardiology Univeristy Hospital of Zurich	Zurich
Switzerland	Universisty Hospital of Zurich, Cardiovascular Center Cardiology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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