Elective Coronary Artery Bypass Graft Surgery Clinical Trial
Official title:
Study of Anti-inflammatory Treatment With Colchicine in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery to Reduce Reperfusion Damage
| Verified date | November 2014 |
| Source | G.Gennimatas General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Greece: Ethics Committee |
| Study type | Interventional |
There is evidence that inflammatory processes may play a key role during surgical myocardial reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may lead to reduction in periprocedural infarct size, when administered during elective coronary artery bypass graft surgery.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | November 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - The study will enroll patients 18 years old or older who are eligible to undergo CABG surgery. Exclusion Criteria: Excluded are patients: - with age > 80 years old - scheduled for concomitant valve surgery - scheduled for coronary surgery without cardiopulmonary bypass - with peripheral vascular disease a?ecting the upper limbs - with acute coronary syndrome within the previous 4 weeks - on inotropic or mechanical circulatory support before induction of anaesthesia - with any disorder that could potentially increase preoperative cTnI concentrations (eg, percutaneous coronary intervention within the previous 6 weeks) - with active inflammatory diseases, infectious diseases or known malignancy - under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents - with known hypersensitivity-allergy to colchicine - under chronic treatment with colchicine - with severe renal failure (eGFR < 35 ml/min/1.73 m2) - with hepatic failure (Child - Pugh class B or C) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Greece | Athens General Hospital "G. Gennimatas" | Athens | Attika |
| Lead Sponsor | Collaborator |
|---|---|
| G.Gennimatas General Hospital | Evangelismos Hospital |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Myocardial damage marker levels | Days 1-2 post-CABG | No | |
| Secondary | All cause mortality | At one and at six months after CABG | No |