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

NCT ID: NCT01528514

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Bypass Grafting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Curcuminoids

Group Type ACTIVE_COMPARATOR

Curcuminoids

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo in capsule form, 4 capsules 4 times/day

Interventions

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Curcuminoids

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo in capsule form, 4 capsules 4 times/day

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wanwarang Wongcharoen, MD.

OTHER

Sponsor Role lead

Responsible Party

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Wanwarang Wongcharoen, MD.

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wanwarang Wongcharoen, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Chiang Mai University

Locations

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Maharaj Nakorn Chiang Mai hospital

Chiang Mai, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MRG5380258

Identifier Type: -

Identifier Source: org_study_id

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