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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01528514
Other study ID # MRG5380258
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date December 2012

Study information

Verified date September 2019
Source Thailand Research Fund
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2012
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Thailand Maharaj Nakorn Chiang Mai hospital Chiang Mai

Sponsors (1)

Lead Sponsor Collaborator
Wanwarang Wongcharoen, MD.

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of postoperative myocardial infarction participants will be followed for the duration of hospital stay, an expected average of 10 days
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