Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study (CUPID)
Primary Purpose
Coronary Artery Bypass Grafting
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Curcuminoids
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Bypass Grafting focused on measuring Myocardial infarction, Coronary artery bypass grafting, Anti-oxidant, Curcuminoids
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)
Sites / Locations
- Maharaj Nakorn Chiang Mai hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Curcuminoids
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of postoperative myocardial infarction
Secondary Outcome Measures
Full Information
NCT ID
NCT01528514
First Posted
January 31, 2012
Last Updated
September 15, 2019
Sponsor
Wanwarang Wongcharoen, MD.
1. Study Identification
Unique Protocol Identification Number
NCT01528514
Brief Title
Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
Acronym
CUPID
Official Title
The Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wanwarang Wongcharoen, MD.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Grafting
Keywords
Myocardial infarction, Coronary artery bypass grafting, Anti-oxidant, Curcuminoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcuminoids
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcuminoids
Intervention Description
Curcuminoids in capsule form, 4 capsules four times daily (4 grams/day)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo in capsule form, 4 capsules 4 times/day
Primary Outcome Measure Information:
Title
Incidence of postoperative myocardial infarction
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 10 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanwarang Wongcharoen, MD
Organizational Affiliation
Faculty of Medicine, Chiang Mai university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maharaj Nakorn Chiang Mai hospital
City
Chiang Mai
ZIP/Postal Code
50210
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
We'll reach out to this number within 24 hrs