Myocardial Injury
Conditions
Brief summary
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
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.
Interventions
DRUGUbiquinone
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
DRUGPlacebo
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
Sponsors
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* ELECTIVE HIGH RISK NON-CARDIAC SURGERY
Exclusion criteria
* REACTION TO COQ10
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BNP levels following surgery | 48 hours | Peak values |
| Cardiac Troponin levels following surgery | 48 hours | Peak values |
| Change in Troponin levels from baseline to peak | 48 hours | Change from baseline to peak |
| Number of participants with adverse cardiac outcomes following surgery | 48 hours | Myocardial Infarction (MI) and death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with infection | 30 days | Infection diagnosed by a primary care provider |
| Number of participants with a surgical graft failure | 30 days | Primary surgical site graft failure |
| Number of participants who died | 30 days | All cause mortality |
| Rate of readmission at 1 year following discharge | 1 year | Any admission to hospital for 1 year post discharge |
| Length of stay | 30 days | Length of stay in days for index hospitalization |
| Number of participants requiring coronary revascularization | 30 days | Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) |
| Number of participants with new heart failure | 30 days | Heart failure, newly diagnosed by cardiologist |
| Number of participants with new onset Atrial Fibrillation (A-Fib) | 30 days | New onset A-Fib |
Countries
United States
Outcome results
None listed