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

Primary Purpose

Stable Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
flavanol-rich drink vs flavanol-free drink
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stable Coronary Heart Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Center Cardiology Univeristy Hospital of Zurich
  • Universisty Hospital of Zurich, Cardiovascular Center Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

flavanol-containing drink

flavanol-free drink

Arm Description

flavanol-containing drink

flavanol-free drink matched for taste and calories

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2015
Last Updated
January 10, 2019
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02520466
Brief Title
Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease
Official Title
Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Heart Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flavanol-containing drink
Arm Type
Active Comparator
Arm Description
flavanol-containing drink
Arm Title
flavanol-free drink
Arm Type
Placebo Comparator
Arm Description
flavanol-free drink matched for taste and calories
Intervention Type
Dietary Supplement
Intervention Name(s)
flavanol-rich drink vs flavanol-free drink
Intervention Description
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 Outcome Measure Information:
Title
coronary endothelial function as assessed as response to cold pressor test
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F Lüscher, Prof MD
Organizational Affiliation
University Hospital Zurich, Cardiovascular Center Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Center Cardiology Univeristy Hospital of Zurich
City
Zurich
Country
Switzerland
Facility Name
Universisty Hospital of Zurich, Cardiovascular Center Cardiology
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

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

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