Clinical trial NCT03956017: Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery
Official title: Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Myocardial Injury
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2019-05-20
Enrollment: 341
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* ELECTIVE HIGH RISK NON-CARDIAC SURGERY

Exclusion Criteria:

* REACTION TO COQ10

Primary outcomes:
measure: BNP levels following surgery
timeFrame: 48 hours
measure: Cardiac Troponin levels following surgery
timeFrame: 48 hours
measure: Change in Troponin levels from baseline to peak
timeFrame: 48 hours
measure: Number of participants with adverse cardiac outcomes following surgery
timeFrame: 48 hours
Secondary outcomes:
measure: Number of participants who died
timeFrame: 30 days
measure: Number of participants requiring coronary revascularization
timeFrame: 30 days
measure: Number of participants with new heart failure
timeFrame: 30 days
measure: Number of participants with new onset Atrial Fibrillation (A-Fib)
timeFrame: 30 days
measure: Number of participants with infection
timeFrame: 30 days
measure: Number of participants with a surgical graft failure
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Rate of readmission at 1 year following discharge
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Va Medical Center
state: Minnesota
Study officials:
affiliation: SITE PI
name: EDWARD MCFALLS, MD
role: STUDY_CHAIR
References:
citation: 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.