Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study

• Status: Unknown status
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Perioperative Myocardial Infarction (PMI) is a major contributor to perioperative mortality and morbidity with overall incidence of 5-16% (1, 2). It is associated with increased 30-day mortality of 11.6% vs 2.2% of patients without PMI in non-cardiac surgical patients (1). However, its recognition and diagnosis remains challenging as the typical symptoms and findings of ischemic MI may be masked by post-operative changes and pain management.

In this study, the investigators hope to determine if colchicine decreases the incidence of MINS in high risk surgical patients undergoing non-cardiac surgery and optimally establish colchicine as a viable therapy to improve perioperative cardiovascular outcome in those patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborators: Providence Health & Services; Vancouver Coastal Health
• Treatments: Colchicine

Criteria

Inclusion Criteria:

Any patient undergoing non-cardiac surgery is eligible if (s)he is:

• Aged 45 years of age or older

• Expected to be admitted for >48 hours

• Have a preoperative BNP value of 92 or higher, or a NT-proBNP value of 300 or higher,

• If a BNP or NT-proBNP is not available, then the patient must fulfill at least one of the criteria for moderate to high risk of perioperative myocardial injury (see below):

Moderate to high risk for perioperative myocardial injury criteria:

• History of coronary artery disease

• History of peripheral artery disease

• History of stroke

• Undergoing major vascular surgery

• Any 3 of the following 9 criteria:

1. Age 70 years or greater

2. Undergoing intraperitoneal, retroperitoneal, intrathoracic, or major orthopaedic surgery

3. History of heart failure

4. History of transient ischemic attack

5. History of diabetes requiring insulin or oral hypoglycemic medications

6. Hypertension

7. Serum creatinine greater than 170 mmol/mL

8. History of smoking within 2 years of surgery

9. Undergoing urgent or emergent surgery

Exclusion Criteria:

Patients will be ineligible for the study if (s)he has:

• An allergy to colchicine

• Myelodysplastic syndrome

• An estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2

• Anticipated post-operative administration of cyclosporine, ketoconazole, itraconazole, protease inhibitors, or clarithromycin