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

This study is currently recruiting participants.
Verified February 2012 by Thailand Research Fund
Sponsor:
Information provided by (Responsible Party):
Wanwarang Wongcharoen, MD., Thailand Research Fund
ClinicalTrials.gov Identifier:
NCT01528514
First received: January 31, 2012
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Bypass Grafting
 Dietary Supplement: Curcuminoids
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thailand Research Fund:

Primary Outcome Measures:
  • Incidence of postoperative myocardial infarction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wanwarang Wongcharoen, MD., Principal investigator, Thailand Research Fund
ClinicalTrials.gov Identifier: NCT01528514     History of Changes
Other Study ID Numbers: MRG5380258
Study First Received: January 31, 2012
Last Updated: February 7, 2012
Health Authority: Thailand: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013