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Trial record 46 of 533 for:    Taste Disorders

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

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ClinicalTrials.gov Identifier: NCT02520466
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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
Stable Coronary Heart Disease Dietary Supplement: flavanol-rich drink vs flavanol-free drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : July 2012
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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.




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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520466


Locations
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Switzerland
Cardiovascular Center Cardiology Univeristy Hospital of Zurich
Zurich, Switzerland
Universisty Hospital of Zurich, Cardiovascular Center Cardiology
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Thomas F Lüscher, Prof MD University Hospital Zurich, Cardiovascular Center Cardiology

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02520466     History of Changes
Other Study ID Numbers: EK2012-0201
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases