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Completed

NCT Number: NCT02520466

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

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)

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Key information

Conditions

Stable Coronary Heart Disease

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Center Cardiology Univeristy Hospital of Zurich, Zurich, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flavanol-rich drink vs flavanol-free drink

Dietary 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

Primary outcomes

  1. coronary endothelial function as assessed as response to cold pressor test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2015
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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