Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study (CUPID)

September 15, 2019 updated by: Wanwarang Wongcharoen, MD.

The Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study

It is well-established that myocardial infarction (MI) associated with coronary artery bypass graft surgery (CABG) predicts the poor outcome. Nevertheless, the cardioprotective therapies to limit myocardial injury after CABG are lacking. Previous studies have shown that curcuminoids suppress pro-inflammatory cytokines during cardiopulmonary bypass surgery and decrease the occurrence of cardiomyocytic apoptosis after cardiac ischemia/reperfusion injury in animal models. The investigators aim to evaluate whether curcuminoids prevent MI after CABG, compared to placebo.

Study Overview

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chiang Mai, Thailand, 50210
        • Maharaj Nakorn Chiang Mai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients undergoing CABG without valve surgery

Exclusion Criteria:

  • emergency cardiac surgery
  • any increase in CK-MB above upper limit of normal range (ULN) at the time of randomization
  • patients with cholestatic jaundice (total bilirubin > 2-fold ULN)
  • severe liver disease (AST or ALT > 3-fold ULN)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo in capsule form, 4 capsules 4 times/day
Active Comparator: Curcuminoids
Curcuminoids in capsule form, 4 capsules four times daily (4 grams/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative myocardial infarction
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wanwarang Wongcharoen, MD, Faculty of Medicine, Chiang Mai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 15, 2019

Last Verified

September 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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