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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ubiquinone | Experimental | Take oral tablets as directed (2x200 mg for 3 days prior to surgery) |
|
| Placebo | Placebo Comparator | Take oral tablets as directed (2x200 mg for 3 days prior to surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubiquinone | Drug | Take oral tablets as directed (2x200 mg for 3 days prior to surgery) |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| EDWARD MCFALLS, MD | SITE PI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Va Medical Center | Minneapolis | Minnesota | 55417 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31629852 | Derived | Khan A, Johnson DK, Carlson S, Hocum-Stone L, Kelly RF, Gravely AA, Mbai M, Green DL, Santilli S, Garcia S, Adabag S, McFalls EO. NT-Pro BNP Predicts Myocardial Injury Post-vascular Surgery and is Reduced with CoQ10: A Randomized Double-Blind Trial. Ann Vasc Surg. 2020 Apr;64:292-302. doi: 10.1016/j.avsg.2019.09.017. Epub 2019 Oct 17. |
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Sharing plan will be left at the discretion of the VA funding organization and statistical site.
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| ID | Term |
|---|---|
| D014451 | Ubiquinone |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D016227 | Benzoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D003067 | Coenzymes |
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| Placebo | Drug | Take oral tablets as directed (2x200 mg for 3 days prior to surgery) |
|
|
| 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 |
| D045762 |
| Enzymes and Coenzymes |