Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery
- Registration Number
- NCT03956017
- Lead Sponsor
- Minneapolis Veterans Affairs Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 341
- ELECTIVE HIGH RISK NON-CARDIAC SURGERY
- REACTION TO COQ10
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Take oral tablets as directed (2x200 mg for 3 days prior to surgery) Ubiquinone Ubiquinone Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of participants who died 30 days All cause mortality
Number of participants with new onset Atrial Fibrillation (A-Fib) 30 days New onset A-Fib
Rate of readmission at 1 year following discharge 1 year Any admission to hospital for 1 year post discharge
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 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
Length of stay 30 days Length of stay in days for index hospitalization
Trial Locations
- Locations (1)
Va Medical Center
🇺🇸Minneapolis, Minnesota, United States