Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-16 @ 6:32 AM
Study NCT ID:
NCT02520466
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2015-08-07', 'studyFirstSubmitQcDate': '2015-08-07', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coronary endothelial function as assessed as response to cold pressor test', 'timeFrame': '2 hours', '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.\n\nIn a subset of patients daily consumption of a flavanol-drink will be assessed and outcomes measured after 3-4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stable Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': '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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention\n\n* Age 20 - 80\n* Written obtained informed consent\n\nExclusion Criteria:\n\n* Acute ST-elevation myocardial infarction\n* Acute non-ST-elevation myocardial infarction (enzyme positive)\n* Ventricular tachy-arrythmias or AV-Block \\>I°\n* Renal insufficiency (GFR MDRD \\< 30ml/min) or liver disease (ALT or AST \\>150 IU)\n* Pregnancy\n* Known allergy to compounds of cocoa product\n* Known allergy to contrast media\n* Known allergy to nuts\n* Intolerance to coffein and theobromin\n* Acute infectious disease\n* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)\n* Participation in another study within the last month\n* Concomitant vitamin supplements and herbal remedies, as well as fruit and tea extracts\n* No study visits ± 1 week before Eastern, Christmas and New Year holyday (altered eating habits)\n* Extreme eating habits (as assessed by a questionnaire)\n* Alcohol or drug abuse\n* Lactose intolerance'}, 'identificationModule': {'nctId': 'NCT02520466', 'briefTitle': 'Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'EK2012-0201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'flavanol-containing drink', 'description': 'flavanol-containing drink', 'interventionNames': ['Dietary Supplement: flavanol-rich drink vs flavanol-free drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'flavanol-free drink', 'description': 'flavanol-free drink matched for taste and calories', 'interventionNames': ['Dietary Supplement: flavanol-rich drink vs flavanol-free drink']}], 'interventions': [{'name': 'flavanol-rich drink vs flavanol-free drink', 'type': 'DIETARY_SUPPLEMENT', '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', 'armGroupLabels': ['flavanol-containing drink', 'flavanol-free drink']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Cardiovascular Center Cardiology Univeristy Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universisty Hospital of Zurich, Cardiovascular Center Cardiology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Thomas F Lüscher, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Cardiovascular Center Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}