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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT02520466
Collaborator
(none)
37
Enrollment
2
Locations
2
Arms
77
Duration (Months)
18.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: flavanol-rich drink vs flavanol-free drink
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: flavanol-containing drink

flavanol-containing drink

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
Placebo Comparator: flavanol-free drink

flavanol-free drink matched for taste and calories

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardiovascular Center Cardiology Univeristy Hospital of Zurich Zurich Switzerland
2 Universisty Hospital of Zurich, Cardiovascular Center Cardiology Zurich Switzerland

Sponsors and Collaborators

  • University of Zurich

Investigators

  • Principal Investigator: Thomas F Lüscher, Prof MD, University Hospital Zurich, Cardiovascular Center Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT02520466
Other Study ID Numbers:
  • EK2012-0201
First Posted:
Aug 11, 2015
Last Update Posted:
Jan 11, 2019
Last Verified:
Jan 1, 2019
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Study Results

No Results Posted as of Jan 11, 2019