Stable Coronary Heart DiseaseNCT02520466
Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease
A study testing flavanol-rich drink vs flavanol-free drink in people with Stable Coronary Heart Disease, run by University of Zurich at 2 sites in Switzerland.
Trial 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) Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stable Coronary Heart Disease
- What is being tested?
- flavanol-rich drink vs flavanol-free drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jul 2012to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention
- Age 20 - 80
- Written obtained informed consent
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Cardiovascular Center Cardiology Univeristy Hospital of Zurich
Zurich
Universisty Hospital of Zurich, Cardiovascular Center Cardiology
Zurich
About this study
Official title: Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease
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)
- Conditions
- Stable Coronary Heart Disease
- Being tested
- flavanol-rich drink vs flavanol-free drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flavanol-rich drink vs flavanol-free drinkDietary 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
| Study group | Role | What they receive |
|---|---|---|
| flavanol-containing drink | Active comparator | flavanol-containing drink Receives: Dietary Supplement: flavanol-rich drink vs flavanol-free drink |
| flavanol-free drink | Placebo comparator | flavanol-free drink matched for taste and calories Receives: Dietary Supplement: flavanol-rich drink vs flavanol-free drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary endothelial function as assessed as response to cold pressor test
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startJul 2012
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas F Lüscher, Prof MD, Principal investigator, University Hospital Zurich, Cardiovascular Center Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520466
- Sponsor's protocol ID
- EK2012-0201
- Status last verified
- Jan 2019
- First submitted
- 7 Aug 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02520466
- Acronym / sponsor ID
- EK2012-0201
- Conditions
- Stable Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flavanol-containing drink | Active comparator | Dietary Supplement: flavanol-rich drink vs flavanol-free drinkflavanol-containing drink |
| flavanol-free drink | Placebo comparator | Dietary Supplement: flavanol-rich drink vs flavanol-free drinkflavanol-free drink matched for taste and calories |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention
- Age 20 - 80
- Written obtained informed consent
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flavanol-rich drink vs flavanol-free drinkPatients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content | Dietary supplement | flavanol-containing drink, flavanol-free drink |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas F Lüscher, Prof MD principal investigator
University Hospital Zurich, Cardiovascular Center Cardiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flavanol-rich drink vs flavanol-free drink in people with Stable Coronary Heart Disease, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coronary endothelial function as assessed as response to cold pressor test (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.