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Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study (CUPID)

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ClinicalTrials.gov Identifier: NCT01528514
Recruitment Status : Unknown
Verified February 2012 by Wanwarang Wongcharoen, MD., Thailand Research Fund.
Recruitment status was:  Recruiting
First Posted : February 8, 2012
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
Wanwarang Wongcharoen, MD., Thailand Research Fund

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Grafting Dietary Supplement: Curcuminoids Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
Study Start Date : September 2009
Primary Completion Date : September 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Incidence of postoperative myocardial infarction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528514


Contacts
Contact: Wanwarang Wongcharoen, MD +66 53 946713 bwanwarang@yahoo.com

Locations
Thailand
Maharaj Nakorn Chiang Mai hospital Recruiting
Muang, Chiang Mai, Thailand, 50210
Contact: Wanwarang Wongcharoen, MD    +66 53 946713    bwanwarang@yahoo.com   
Principal Investigator: Wanwarang Wongcharoen, MD         
Sponsors and Collaborators
Wanwarang Wongcharoen, MD.
Investigators
Principal Investigator: Wanwarang Wongcharoen, MD Faculty of Medicine, Chiang Mai university

Responsible Party: Wanwarang Wongcharoen, MD., Principal investigator, Thailand Research Fund
ClinicalTrials.gov Identifier: NCT01528514     History of Changes
Other Study ID Numbers: MRG5380258
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by Wanwarang Wongcharoen, MD., Thailand Research Fund:
Myocardial infarction
Coronary artery bypass grafting
Anti-oxidant
Curcuminoids

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases