Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery (ACE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Injury
• Intervention / Treatment: Drug: Ubiquinone; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 341
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Va Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ELECTIVE HIGH RISK NON-CARDIAC SURGERY

Exclusion Criteria:

• REACTION TO COQ10

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ubiquinone; Take oral tablets as directed (2x200 mg for 3 days prior to surgery)	Drug: Ubiquinone; Take oral tablets as directed (2x200 mg for 3 days prior to surgery); Other Names: CoQ10, Coenzyme Q10
Placebo Comparator: Placebo; Take oral tablets as directed (2x200 mg for 3 days prior to surgery)	Drug: Placebo; Take oral tablets as directed (2x200 mg for 3 days prior to surgery); Other Names: Sugar pill, inactive substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center
• Investigators: Study Chair: EDWARD MCFALLS, MD, Site PI

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2013
• Primary Completion (Anticipated): August 4, 2022
• Study Completion (Anticipated): August 4, 2022

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: IND 119600 Coenzyme Q10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Sharing plan will be left at the discretion of the VA funding organization and statistical site.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No