Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery
Overview
- Phase
- Early Phase 1
- Intervention
- Ubiquinone
- Conditions
- Myocardial Injury
- Sponsor
- Minneapolis Veterans Affairs Medical Center
- Enrollment
- 341
- Locations
- 1
- Primary Endpoint
- Change in Troponin levels from baseline to peak
- Last Updated
- 4 years ago
Overview
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.
Investigators
Edward McFalls
CARDIOLOGIST
Minneapolis Veterans Affairs Medical Center
Eligibility Criteria
Inclusion Criteria
- •ELECTIVE HIGH RISK NON-CARDIAC SURGERY
Exclusion Criteria
- •REACTION TO COQ10
Arms & Interventions
Ubiquinone
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
Intervention: Ubiquinone
Placebo
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Troponin levels from baseline to peak
Time Frame: 48 hours
Change from baseline to peak
Cardiac Troponin levels following surgery
Time Frame: 48 hours
Peak values
BNP levels following surgery
Time Frame: 48 hours
Peak values
Number of participants with adverse cardiac outcomes following surgery
Time Frame: 48 hours
Myocardial Infarction (MI) and death
Secondary Outcomes
- Number of participants who died(30 days)
- Number of participants with new onset Atrial Fibrillation (A-Fib)(30 days)
- Rate of readmission at 1 year following discharge(1 year)
- Number of participants requiring coronary revascularization(30 days)
- Number of participants with new heart failure(30 days)
- Number of participants with infection(30 days)
- Number of participants with a surgical graft failure(30 days)
- Length of stay(30 days)