NCT01528514

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

January 31, 2012

Last Update Submit

September 15, 2019

Conditions

Coronary Artery Bypass Grafting

Keywords

Myocardial infarctionCoronary artery bypass graftingAnti-oxidantCurcuminoids

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative myocardial infarction

    participants will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (2)

Curcuminoids

ACTIVE COMPARATOR
Dietary Supplement: Curcuminoids

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

CurcuminoidsDIETARY_SUPPLEMENT

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

Curcuminoids
PlaceboOTHER

Placebo in capsule form, 4 capsules 4 times/day

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing CABG without valve surgery

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharaj Nakorn Chiang Mai hospital

Chiang Mai, 50210, Thailand

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Diarylheptanoids

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

HeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Wanwarang Wongcharoen, MD

    Faculty of Medicine, Chiang Mai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 8, 2012

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2012

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

TH(1)