Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02520466 |
Date of registration:
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07/08/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease
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Scientific title:
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Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease |
Date of first enrolment:
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July 2012 |
Target sample size:
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37 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02520466 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Thomas F Lüscher, Prof MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Zurich, Cardiovascular Center Cardiology |
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Key inclusion & exclusion 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
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stable Coronary Heart Disease
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Intervention(s)
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Dietary Supplement: flavanol-rich drink vs flavanol-free drink
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Primary Outcome(s)
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coronary endothelial function as assessed as response to cold pressor test
[Time Frame: 2 hours]
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Secondary ID(s)
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EK2012-0201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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