Coronary Heart DiseasePolyphemusNCT02045134
Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery
A study testing High-anthocyanin rich corn flour in people with Coronary Heart Disease, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after a cardiac surgery. Both systemic inflammation and oxidative stress play a role in the initiation of POAF after a cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- High-anthocyanin rich corn flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Sep 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of sinus rhythm on the screening electrocardiogram
- first-time elective open heart surgery
Who cannot join
- absence of sinus rhythm at screening
- known allergy or intolerance to gluten or anthocyanin compound
- regularly consuming of anthocyanin or antioxidant supplements,
- being currently pregnant,
- existing or planned cardiac transplant or use of ventricular assist device,
- being unable or unwilling to provide informed consent,
- history of hepatic or renal disease,
- history of cancer history of substance abuse
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS INM Neuromed, Department of Epidemiology and Prevention
Pozzilli, IS, 86077
About this study
Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after a cardiac surgery. Both systemic inflammation and oxidative stress play a role in the initiation of POAF after a cardiac surgery. Epidemiological studies show a significant inverse correlation between cardiovascular risk and consumption of polyphenol-rich foods (PRFs), due to antioxidant, vasorelaxant and antithrombotic properties of their polyphenolic components. The main objective of this study is to evaluate the effect of polyphenol-rich food supplementation on post-operative atrial fibrillation (POAF) in patients undergoing an open heart surgery (mainly coronary artery bypass grafts (CABG) and valve replacement or repaired (VR))
Read the detailed description
- Study Rationale: An open heart surgery (OHS) induces injury of the vessel wall and is characterized by post-operative complications. Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after cardiac surgery. Both systemic inflammation and oxidative stress play a role in the initiation of POAF after a cardiac surgery. Consumption of polyphenol-rich foods (PRFs), such as fruits and vegetables, and beverages derived from plants, such as cocoa, red wine and tea, may represent a beneficial diet in terms of cardiovascular protection. Indeed, epidemiological studies demonstrate a significant inverse correlation between PRFs consumption and cardiovascular risk, due to antioxidant, vasorelaxant and antithrombotic properties of their polyphenolic components. In particular, procyanidins from grape seeds are the principal vasoactive polyphenols in red wine and protect endothelial cells from oxidative damage. However, there are no studies that have addressed the relationship of PRFs consumption with prognosis in patients undergoing an OHS.
- Aim of the study. The main objectives of this project are to evaluate the association between the effect of polyphenol-rich food supplementation and post-operative atrial fibrillation (POAF) in patients undergoing an OHS.
- Study design: Multicentre, randomized, placebo-controlled double-blind trial with 2 parallel arms: soluble corn flour at high content in anthocyanins and placebo. Placebo consists of soluble corn flour not rich in anthocyanins. The treatment will start at hospital admission until one day before cardiac surgery, and continue (4 days) after extubation and when the patients are reallocated to eat.
- Study Population and recruitment: A total of 350 consecutive CAD patients undergoing to CABG or VR will be recruited. Participants will be identified at the Department of Cardiovascular disease of the clinical centers. Eligible subjects will be recruited at their first surgical consultation and subsequently referred to the research investigators. The research staff in charge of the recruitment will pre-screen participants on the basis of inclusion/exclusion criteria and will explain the study at this time. The main inclusion criteria are :age 18 years or older, presence of sinus rhythm on the screening electrocardiogram, first-time elective open heart surgery. Exclusion criteria are: absence of sinus rhythm at screening, known allergy or intolerance to gluten or anthocyanin compound, regularly consuming of anthocyanin or antioxidant supplements, being currently pregnant, existing or planned cardiac transplant or use of ventricular assist device, or being unable or unwilling to provide informed consent, known history of hepatic or renal disease, cancer and subjects with a history of substance abuse. Once signed the informed consent, if the subject is eligible for the study according to the inclusion/exclusion criteria, he/she will be included into the trial and randomised, using prepared envelopes blinded to the study investigators, to receive daily high-anthocyanin supplement or placebo. Subjects will start the dietary intervention at hospital admission until one day before cardiac surgery. Then they will continue the supplementation as soon they are reallocated to eat for the next 4 days after the surgery. Each patient will be asked to answer electronic questionnaires to collect personal information and medical history (social status, previous disease or surgical interventions, risk factors and family history for cardiovascular disease, drug use). Other relevant clinical data as well as measures of clinical outcomes will be collected by medical records. A 1-year food frequency questionnaire will be used to investigate dietary habits. Electrocardiographic, blood pressure, anthropometric measurements will be collected using standardized methods. During the hospitalization, time in intensive therapy, post-surgical course, specific drug therapy, post-surgical complications, fatal and non-fatal cardiovascular events, re-intervention of revascularization and bypass occlusion will be recorded. Venous blood (max 30 mL) will be collected before PRFs/placebo supplementation and 24 h and 72 h after the cardiac surgery. The patients will undergo OHS according to the indication and good practice procedures normally applied in the Department of Cardio-surgery of participant clinical centers. All patients will receive the pharmacological therapy and the lifestyle change advice according to the best clinical practice for the specific disease and surgical intervention.
- Evaluation criteria: The primary end point will be the occurrence of postoperative AF of at least 30 seconds' duration and documented by rhythm strip or 12-lead ECG or treated with pharmacological or electrical cardioversion.
- Power calculation: Fixing alpha=0.05, beta=0.2, the incidence of POAF =38% with a sample size of N=350 CABG patients (half of them will be randomize to PRFs supplementation) and a 22% of drop-out, we can observe a relative risk <0.64 in reduction of POAF in the intervention group.
- Statistical analysis. All analyses will be performed using statistical analysis software SAS (SAS, 9.1.3 for Windows, Cary, NC: SAS Institute Inc.1989). All individuals enrolled will be included in the analysis. Descriptive summaries will be presented for all the individuals, and for subgroups of individuals. Statistical tests will be carried out for exploratory purposes, as appropriate. The descriptive analysis of nominal/ordinal data will comprise tabulation of frequency and percentages. Chi-square test (or Fisher exact test in the presence of small frequencies) will be used to compare categories. The descriptive analysis of continuous data will comprise the mean, standard deviation, median, extreme values, and 95% confidence interval. OHS patients will be randomized to receive a short term supplementation of PRFs or placebo (J Nutr 2008), following the scheme of a controlled randomised double-blind clinical trial. POAF occurence will be compared in PRFs supplemented and control groups to assess the efficacy and safety of the intervention. The "intention to treat" principle will be adopted for the analysis of the combined endpoints.
- Conditions
- Coronary Heart Disease
- Being tested
- Placebo, High-anthocyanin rich corn flour
- Keywords
- Post Operative Atrial Fibrillation after a cardiac surgery
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Soluble corn flour not rich in anthocyanins
High-anthocyanin rich corn flourDietary supplement
Soluble corn flour at high content in anthocyanins
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Soluble corn flour not rich in anthocyanins Receives: Dietary Supplement: Placebo |
| High-anthocyanin rich corn flour | Active comparator | Soluble corn flour at high content in anthocyanins Receives: Dietary Supplement: High-anthocyanin rich corn flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Atrial Fibrillation
Reduction of Post Operative Atrial Fibrillation after a cardiac surgery
Measured: up to 10 days after cardiac surgery
Secondary outcomes (3)
intensive unit and post-operative hospital-stay
reduction of intensive unit and post-operative hospital-stay
Measured: up to hospital discharge (average period 10 days)
cumulative post-operative complications
reduction of occurrence of cumulative post-operative complications (renal failure, pulmonary failure (time frame: up to hospital discharge); fatal and non-fatal cardiovascular events and all-causes mortality) (time frame: up to 30 days after cardiac surgery)
Measured: up to 30 days after cardiac surgery
circulating inflammatory markers
additional end-point will be circulating inflammatory markers such as C reactive protein (CRP), interleukin 6 (IL6), D-dimers, plasma proteome
Measured: up to 24 hours after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: low participation rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Licia Iacoviello, Neuromed IRCCS
- Investigators
- Licia Iacoviello, MD, PhD, Principal investigator, IRCCS INM Neuromed, Department of Epidemiology and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045134
- Sponsor's protocol ID
- Neuromed-GR-2008-1146478
- Acronym
- Polyphemus
- Status last verified
- Jul 2016
- First submitted
- 20 Jan 2014
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Costanzo S, di Niro V, Di Castelnuovo A, Gianfagna F, Donati MB, de Gaetano G, Iacoviello L. Prevention of postoperative atrial fibrillation in open heart surgery patients by preoperative supplementation of n-3 polyunsaturated fatty acids: an updated meta-analysis. J Thorac Cardiovasc Surg. 2013 Oct;146(4):906-11. doi: 10.1016/j.jtcvs.2013.03.015. Epub 2013 Apr 12.
PubMed 23587470
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02045134
- Acronym / sponsor ID
- Polyphemus / Neuromed-GR-2008-1146478
- Conditions
- Coronary Heart Disease
- Keywords
- Post Operative Atrial Fibrillation after a cardiac surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low participation rate
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Jan 2014 (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.
Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after a cardiac surgery. Both systemic inflammation and oxidative stress play a role in the initiation of POAF after a cardiac surgery. Epidemiological studies show a significant inverse correlation between cardiovascular risk and consumption of polyphenol-rich foods (PRFs), due to antioxidant, vasorelaxant and antithrombotic properties of their polyphenolic components. The main objective of this study is to evaluate the effect of polyphenol-rich food supplementation on post-operative atrial fibrillation (POAF) in patients undergoing an open heart surgery (mainly coronary artery bypass grafts (CABG) and valve replacement or repaired (VR))
Detailed description
- Study Rationale: An open heart surgery (OHS) induces injury of the vessel wall and is characterized by post-operative complications. Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after cardiac surgery. Both systemic inflammation and oxidative stress play a role in the initiation of POAF after a cardiac surgery. Consumption of polyphenol-rich foods (PRFs), such as fruits and vegetables, and beverages derived from plants, such as cocoa, red wine and tea, may represent a beneficial diet in terms of cardiovascular protection. Indeed, epidemiological studies demonstrate a significant inverse correlation between PRFs consumption and cardiovascular risk, due to antioxidant, vasorelaxant and antithrombotic properties of their polyphenolic components. In particular, procyanidins from grape seeds are the principal vasoactive polyphenols in red wine and protect endothelial cells from oxidative damage. However, there are no studies that have addressed the relationship of PRFs consumption with prognosis in patients undergoing an OHS.
- Aim of the study. The main objectives of this project are to evaluate the association between the effect of polyphenol-rich food supplementation and post-operative atrial fibrillation (POAF) in patients undergoing an OHS.
- Study design: Multicentre, randomized, placebo-controlled double-blind trial with 2 parallel arms: soluble corn flour at high content in anthocyanins and placebo. Placebo consists of soluble corn flour not rich in anthocyanins. The treatment will start at hospital admission until one day before cardiac surgery, and continue (4 days) after extubation and when the patients are reallocated to eat.
- Study Population and recruitment: A total of 350 consecutive CAD patients undergoing to CABG or VR will be recruited. Participants will be identified at the Department of Cardiovascular disease of the clinical centers. Eligible subjects will be recruited at their first surgical consultation and subsequently referred to the research investigators. The research staff in charge of the recruitment will pre-screen participants on the basis of inclusion/exclusion criteria and will explain the study at this time. The main inclusion criteria are :age 18 years or older, presence of sinus rhythm on the screening electrocardiogram, first-time elective open heart surgery. Exclusion criteria are: absence of sinus rhythm at screening, known allergy or intolerance to gluten or anthocyanin compound, regularly consuming of anthocyanin or antioxidant supplements, being currently pregnant, existing or planned cardiac transplant or use of ventricular assist device, or being unable or unwilling to provide informed consent, known history of hepatic or renal disease, cancer and subjects with a history of substance abuse. Once signed the informed consent, if the subject is eligible for the study according to the inclusion/exclusion criteria, he/she will be included into the trial and randomised, using prepared envelopes blinded to the study investigators, to receive daily high-anthocyanin supplement or placebo. Subjects will start the dietary intervention at hospital admission until one day before cardiac surgery. Then they will continue the supplementation as soon they are reallocated to eat for the next 4 days after the surgery. Each patient will be asked to answer electronic questionnaires to collect personal information and medical history (social status, previous disease or surgical interventions, risk factors and family history for cardiovascular disease, drug use). Other relevant clinical data as well as measures of clinical outcomes will be collected by medical records. A 1-year food frequency questionnaire will be used to investigate dietary habits. Electrocardiographic, blood pressure, anthropometric measurements will be collected using standardized methods. During the hospitalization, time in intensive therapy, post-surgical course, specific drug therapy, post-surgical complications, fatal and non-fatal cardiovascular events, re-intervention of revascularization and bypass occlusion will be recorded. Venous blood (max 30 mL) will be collected before PRFs/placebo supplementation and 24 h and 72 h after the cardiac surgery. The patients will undergo OHS according to the indication and good practice procedures normally applied in the Department of Cardio-surgery of participant clinical centers. All patients will receive the pharmacological therapy and the lifestyle change advice according to the best clinical practice for the specific disease and surgical intervention.
- Evaluation criteria: The primary end point will be the occurrence of postoperative AF of at least 30 seconds' duration and documented by rhythm strip or 12-lead ECG or treated with pharmacological or electrical cardioversion.
- Power calculation: Fixing alpha=0.05, beta=0.2, the incidence of POAF =38% with a sample size of N=350 CABG patients (half of them will be randomize to PRFs supplementation) and a 22% of drop-out, we can observe a relative risk <0.64 in reduction of POAF in the intervention group.
- Statistical analysis. All analyses will be performed using statistical analysis software SAS (SAS, 9.1.3 for Windows, Cary, NC: SAS Institute Inc.1989). All individuals enrolled will be included in the analysis. Descriptive summaries will be presented for all the individuals, and for subgroups of individuals. Statistical tests will be carried out for exploratory purposes, as appropriate. The descriptive analysis of nominal/ordinal data will comprise tabulation of frequency and percentages. Chi-square test (or Fisher exact test in the presence of small frequencies) will be used to compare categories. The descriptive analysis of continuous data will comprise the mean, standard deviation, median, extreme values, and 95% confidence interval. OHS patients will be randomized to receive a short term supplementation of PRFs or placebo (J Nutr 2008), following the scheme of a controlled randomised double-blind clinical trial. POAF occurence will be compared in PRFs supplemented and control groups to assess the efficacy and safety of the intervention. The "intention to treat" principle will be adopted for the analysis of the combined endpoints.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoluble corn flour not rich in anthocyanins |
| High-anthocyanin rich corn flour | Active comparator | Dietary Supplement: High-anthocyanin rich corn flourSoluble corn flour at high content in anthocyanins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of sinus rhythm on the screening electrocardiogram
- first-time elective open heart surgery
Key exclusion criteria (8 listed)
- absence of sinus rhythm at screening
- known allergy or intolerance to gluten or anthocyanin compound
- regularly consuming of anthocyanin or antioxidant supplements,
- being currently pregnant,
- existing or planned cardiac transplant or use of ventricular assist device,
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 |
|---|---|---|
| PlaceboSoluble corn flour not rich in anthocyanins | Dietary supplement | Placebo |
| High-anthocyanin rich corn flourSoluble corn flour at high content in anthocyanins | Dietary supplement | High-anthocyanin rich corn flour |
Primary outcome
Post Operative Atrial Fibrillation
Time frame: up to 10 days after cardiac surgery
Reduction of Post Operative Atrial Fibrillation after a cardiac surgery
3 secondary outcomes
intensive unit and post-operative hospital-stay
Time frame: up to hospital discharge (average period 10 days)
cumulative post-operative complications
Time frame: up to 30 days after cardiac surgery
circulating inflammatory markers
Time frame: up to 24 hours after cardiac surgery
Results and safety
The study was stopped early (reason given: low participation rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Background: PubMed 23587470Costanzo S, di Niro V, Di Castelnuovo A, Gianfagna F, Donati MB, de Gaetano G, Iacoviello L. Prevention of postoperative atrial fibrillation in open heart surgery patients by preoperative supplementation of n-3 polyunsaturated fatty acids: an updated meta-analysis. J Thorac Cardiovasc Surg. 2013 Oct;146(4):906-11. doi: 10.1016/j.jtcvs.2013.03.015. Epub 2013 Apr 12.
- Individual participant dataSharing planned: No
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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.
Licia Iacoviello, MD, PhD principal investigator
IRCCS INM Neuromed, Department of Epidemiology and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-anthocyanin rich corn flour in people with Coronary Heart Disease, run by Neuromed IRCCS at 1 site in Italy.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 was stopped early (reason given: low participation rate). Results are not available in the source record.
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?
Post Operative Atrial Fibrillation (time frame: up to 10 days after cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045134, which also lists 1 linked publication.
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 9 Mar 2018.