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

NCT02520466 | Completed

• 1 other identifier: EK2012-0201
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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)

Conditions

Stable Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

flavanol-containing drink

ACTIVE COMPARATOR

flavanol-containing drink

Dietary Supplement: flavanol-rich drink vs flavanol-free drink

flavanol-free drink

PLACEBO COMPARATOR

flavanol-free drink matched for taste and calories

Dietary Supplement: flavanol-rich drink vs flavanol-free drink

Interventions

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

flavanol-containing drink; flavanol-free drink

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention
• Age 20 - 80
• Written obtained informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

Cardiovascular Center Cardiology Univeristy Hospital of Zurich

Zurich, Switzerland

Location

Universisty Hospital of Zurich, Cardiovascular Center Cardiology

Zurich, Switzerland

Location

Study Officials

• Thomas F Lüscher, Prof MD

  University Hospital Zurich, Cardiovascular Center Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 11, 2015
• Study Start: July 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

CH (2)