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Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery (Polyphemus)

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ClinicalTrials.gov Identifier: NCT02045134
Recruitment Status : Terminated (low participation rate)
First Posted : January 24, 2014
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Licia Iacoviello, Neuromed IRCCS

Brief 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. 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))

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Dietary Supplement: Placebo Dietary Supplement: High-anthocyanin rich corn flour Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Soluble corn flour not rich in anthocyanins
Dietary Supplement: Placebo
Soluble corn flour not rich in anthocyanins
Active Comparator: High-anthocyanin rich corn flour
Soluble corn flour at high content in anthocyanins
Dietary Supplement: High-anthocyanin rich corn flour
Soluble corn flour at high content in anthocyanins



Primary Outcome Measures :
  1. Post Operative Atrial Fibrillation [ Time Frame: up to 10 days after cardiac surgery ]
    Reduction of Post Operative Atrial Fibrillation after a cardiac surgery


Secondary Outcome Measures :
  1. intensive unit and post-operative hospital-stay [ Time Frame: up to hospital discharge (average period 10 days) ]
    reduction of intensive unit and post-operative hospital-stay

  2. cumulative post-operative complications [ Time Frame: up to 30 days after cardiac surgery ]
    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)

  3. circulating inflammatory markers [ Time Frame: up to 24 hours after cardiac surgery ]
    additional end-point will be circulating inflammatory markers such as C reactive protein (CRP), interleukin 6 (IL6), D-dimers, plasma proteome



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of sinus rhythm on the screening electrocardiogram
  • first-time elective open heart surgery

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045134


Locations
Italy
IRCCS INM Neuromed, Department of Epidemiology and Prevention
Pozzilli, IS, Italy, 86077
Sponsors and Collaborators
Neuromed IRCCS
Investigators
Principal Investigator: Licia Iacoviello, MD, PhD IRCCS INM Neuromed, Department of Epidemiology and Prevention

Publications:
Responsible Party: Licia Iacoviello, Laboratory Head, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02045134     History of Changes
Other Study ID Numbers: Neuromed-GR-2008-1146478
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Licia Iacoviello, Neuromed IRCCS:
Post Operative Atrial Fibrillation after a cardiac surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases