- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01528514
Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study (CUPID)
September 15, 2019 updated by: Wanwarang Wongcharoen, MD.
The Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chiang Mai, Thailand, 50210
- Maharaj Nakorn Chiang Mai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo in capsule form, 4 capsules 4 times/day
|
Active Comparator: Curcuminoids
|
Curcuminoids in capsule form, 4 capsules four times daily (4 grams/day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of postoperative myocardial infarction
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
|
participants will be followed for the duration of hospital stay, an expected average of 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wanwarang Wongcharoen, MD, Faculty of Medicine, Chiang Mai University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 31, 2012
First Submitted That Met QC Criteria
February 7, 2012
First Posted (Estimate)
February 8, 2012
Study Record Updates
Last Update Posted (Actual)
September 18, 2019
Last Update Submitted That Met QC Criteria
September 15, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRG5380258
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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