Effects of CUrcuminoids on Coronary Artery byPass graftIn... | NCT01528514

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

NCT01528514

Sponsor

Wanwarang Wongcharoen, MD.

Status

Completed

Last Update Posted

Sep 18, 2019Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Coronary Artery Bypass Grafting

Interventions

Curcuminoids
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009Actual

Primary Completion Date

Sep 2011Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 31, 2012

First Submission Date that Met QC Criteria

Feb 7, 2012

First Posted Date

Feb 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2019

Last Update Posted Date

Sep 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wanwarang Wongcharoen, MD., Principal investigator, Thailand Research FundSponsor-Investigator

Lead Sponsor

Wanwarang Wongcharoen, MD.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Curcuminoids	Active Comparator		Dietary Supplement: Curcuminoids
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Curcuminoids	Dietary Supplement	Curcuminoids in capsule form, 4 capsules four times daily (4 grams/day)	Curcuminoids

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wanwarang Wongcharoen, MD	Faculty of Medicine, Chiang Mai University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maharaj Nakorn Chiang Mai hospital		Chiang Mai		50210	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D036381	Diarylheptanoids

Ancestor Terms

ID	Term
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided