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

Sponsor

Wanwarang Wongcharoen, MD. (Other)

Overall Status

Completed

CT.gov ID

NCT01528514

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass Grafting	Dietary Supplement: Curcuminoids Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Curcuminoids

Dietary Supplement: Curcuminoids

Curcuminoids in capsule form, 4 capsules four times daily (4 grams/day)

Placebo Comparator: Placebo

Other: Placebo

Placebo in capsule form, 4 capsules 4 times/day

Outcome Measures

Primary Outcome Measures

Incidence of postoperative myocardial infarction [participants will be followed for the duration of hospital stay, an expected average of 10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)