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

NCT ID: NCT02520466

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-12-01

Brief Summary

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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)

Detailed Description

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Conditions

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Stable Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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flavanol-containing drink

flavanol-containing drink

Group Type ACTIVE_COMPARATOR

flavanol-rich drink vs flavanol-free drink

Intervention Type 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-free drink

flavanol-free drink matched for taste and calories

Group Type PLACEBO_COMPARATOR

flavanol-rich drink vs flavanol-free drink

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas F Lüscher, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Cardiovascular Center Cardiology

Locations

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Cardiovascular Center Cardiology Univeristy Hospital of Zurich

Zurich, , Switzerland

Site Status

Universisty Hospital of Zurich, Cardiovascular Center Cardiology

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK2012-0201

Identifier Type: -

Identifier Source: org_study_id

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