Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery

Study Overview
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Brief Summary
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N Terminal (NT)-Pro b-type natriuretic peptide (BNP) levels provide incremental value in perioperative risk assessment prior to major non-cardiac surgery. The investigators will test whether pharmacologically lowering this biomarker with daily administration of CoQ10 for 3 days prior to elective vascular surgery will reduce adverse outcomes following the operation.

Detailed Description
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Patients will be screened during their preoperative evaluation. Inclusion criteria include patients in need of an elective vascular operation. Exclusion criteria include urgent operation, known allergic reactions to CoQ10 and participation in another research study. Suitable participants will be randomly assigned to receive either CoQ10 (400 mg per day) versus Placebo for 3 days prior to surgery. A randomized, double blind trial will be used and a research pharmacist will guide the randomization process, blinded to clinical information. The primary end-point measures are BNP levels at 24 and 48 hours following the operation as well as the incidence of myocardial injury, defined by an elevated post-operative high-sensitivity troponin following high risk surgery. Secondary outcome measures include the magnitude of the troponin level, which is the change in the level compared with preoperative baseline troponin levels and adverse clinical cardiac outcomes during the hospitalization period, including death, non-fatal myocardial infarction, diagnosed by a cardiologist who is blinded to the treatment strategy and any coronary artery revascularization procedure. The study will be focused on 30-days following the vascular procedure but the investigators may plan to extend secondary outcome measures for 1 year post-randomization.

Official Title
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Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery

Conditions
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Myocardial Injury

Intervention / Treatment
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* Drug: Ubiquinone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ELECTIVE HIGH RISK NON-CARDIAC SURGERY Exclusion Criteria: REACTION TO COQ10
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ubiquinone<br>Take oral tablets as directed (2x200 mg for 3 days prior to surgery) | Drug: Ubiquinone<br>* Take oral tablets as directed (2x200 mg for 3 days prior to surgery)<br>* Other names: CoQ10, Coenzyme Q10;|
| Placebo Comparator: Placebo<br>Take oral tablets as directed (2x200 mg for 3 days prior to surgery) | Drug: Placebo<br>* Take oral tablets as directed (2x200 mg for 3 days prior to surgery)<br>* Other names: Sugar pill, inactive substance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BNP levels following surgery | Peak values | 48 hours | 
| Cardiac Troponin levels following surgery | Peak values | 48 hours | 
| Change in Troponin levels from baseline to peak | Change from baseline to peak | 48 hours | 
| Number of participants with adverse cardiac outcomes following surgery | Myocardial Infarction (MI) and death | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who died | All cause mortality | 30 days | 
| Number of participants requiring coronary revascularization | Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) | 30 days | 
| Number of participants with new heart failure | Heart failure, newly diagnosed by cardiologist | 30 days | 
| Number of participants with new onset Atrial Fibrillation (A-Fib) | New onset A-Fib | 30 days | 
| Number of participants with infection | Infection diagnosed by a primary care provider | 30 days | 
| Number of participants with a surgical graft failure | Primary surgical site graft failure | 30 days | 
| Length of stay | Length of stay in days for index hospitalization | 30 days | 
| Rate of readmission at 1 year following discharge | Any admission to hospital for 1 year post discharge | 1 year |