NCT02045134

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))

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 9, 2018

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

January 20, 2014

Last Update Submit

March 8, 2018

Conditions

Coronary Heart Disease

Keywords

Post Operative Atrial Fibrillation after a cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Post Operative Atrial Fibrillation

    Reduction of Post Operative Atrial Fibrillation after a cardiac surgery

    up to 10 days after cardiac surgery

Secondary Outcomes (3)

  • intensive unit and post-operative hospital-stay

    up to hospital discharge (average period 10 days)

  • cumulative post-operative complications

    up to 30 days after cardiac surgery

  • circulating inflammatory markers

    up to 24 hours after cardiac surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Soluble corn flour not rich in anthocyanins

Dietary Supplement: Placebo

High-anthocyanin rich corn flour

ACTIVE COMPARATOR

Soluble corn flour at high content in anthocyanins

Dietary Supplement: High-anthocyanin rich corn flour

Interventions

PlaceboDIETARY_SUPPLEMENT

Soluble corn flour not rich in anthocyanins

Placebo
High-anthocyanin rich corn flourDIETARY_SUPPLEMENT

Soluble corn flour at high content in anthocyanins

High-anthocyanin rich corn flour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS INM Neuromed, Department of Epidemiology and Prevention

Pozzilli, IS, 86077, Italy

Location

Related Publications (1)

  • 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.

    PMID: 23587470BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Licia Iacoviello, MD, PhD

    IRCCS INM Neuromed, Department of Epidemiology and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laboratory Head

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 24, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 9, 2018

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)