Coronary Artery Bypass GraftingCUPIDNCT01528514
Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
A study testing Curcuminoids in people with Coronary Artery Bypass Grafting, run by Wanwarang Wongcharoen, MD. at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass Grafting
- What is being tested?
- Curcuminoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing CABG without valve surgery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Bypass Grafting
- Being tested
- Curcuminoids, Placebo
- Keywords
- Myocardial infarction, Coronary artery bypass grafting, Anti-oxidant, Curcuminoids
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminoidsDietary supplement
Curcuminoids in capsule form, 4 capsules four times daily (4 grams/day)
PlaceboOther
Placebo in capsule form, 4 capsules 4 times/day
| Study group | Role | What they receive |
|---|---|---|
| Curcuminoids | Active comparator | Not described Receives: Dietary Supplement: Curcuminoids |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative myocardial infarction
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wanwarang Wongcharoen, MD.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wanwarang Wongcharoen, MD., Thailand Research Fund
- Investigators
- Wanwarang Wongcharoen, MD, Principal investigator, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528514
- Sponsor's protocol ID
- MRG5380258
- Acronym
- CUPID
- Status last verified
- Sep 2019
- First submitted
- 31 Jan 2012
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study
- ClinicalTrials.gov ID
- NCT01528514
- Acronym / sponsor ID
- CUPID / MRG5380258
- Conditions
- Coronary Artery Bypass Grafting
- Keywords
- Myocardial infarction, Coronary artery bypass grafting, Anti-oxidant, Curcuminoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wanwarang Wongcharoen, MD.University, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcuminoids | Active comparator | Dietary Supplement: Curcuminoids |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing CABG without valve surgery
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminoidsCurcuminoids in capsule form, 4 capsules four times daily (4 grams/day) | Dietary supplement | Curcuminoids |
| PlaceboPlacebo in capsule form, 4 capsules 4 times/day | Other | Placebo |
Primary outcome
Incidence of postoperative myocardial infarction
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
Related trials for Coronary Artery Bypass Grafting
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanwarang Wongcharoen, MD principal investigator
Faculty of Medicine, Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcuminoids in people with Coronary Artery Bypass Grafting, run by Wanwarang Wongcharoen, MD. at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative myocardial infarction (time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.