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
About this trial
This is an interventional other trial for Stable Coronary Heart Disease
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
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
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
Learn more about this trial
Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease
We'll reach out to this number within 24 hrs