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

Myocardial Injury Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03956017
• Other study ID #: IND 119600 Coenzyme Q10
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: August 5, 2013
• Est. completion date: August 4, 2022

Study information

• Verified date: August 2021
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 341
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ELECTIVE HIGH RISK NON-CARDIAC SURGERY

Exclusion Criteria:

• REACTION TO COQ10

Related Conditions & MeSH terms

• Myocardial Injury

Intervention

Drug:
• Ubiquinone
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
• Placebo
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)

Locations

Country	Name	City	State
United States	Va Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BNP levels following surgery	Peak values	48 hours
Primary	Cardiac Troponin levels following surgery	Peak values	48 hours
Primary	Change in Troponin levels from baseline to peak	Change from baseline to peak	48 hours
Primary	Number of participants with adverse cardiac outcomes following surgery	Myocardial Infarction (MI) and death	48 hours
Secondary	Number of participants who died	All cause mortality	30 days
Secondary	Number of participants requiring coronary revascularization	Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG)	30 days
Secondary	Number of participants with new heart failure	Heart failure, newly diagnosed by cardiologist	30 days
Secondary	Number of participants with new onset Atrial Fibrillation (A-Fib)	New onset A-Fib	30 days
Secondary	Number of participants with infection	Infection diagnosed by a primary care provider	30 days
Secondary	Number of participants with a surgical graft failure	Primary surgical site graft failure	30 days
Secondary	Length of stay	Length of stay in days for index hospitalization	30 days
Secondary	Rate of readmission at 1 year following discharge	Any admission to hospital for 1 year post discharge	1 year