Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery (ACE)
Sponsor: Minneapolis Veterans Affairs Medical Center
A EARLY_PHASE1 clinical study on Myocardial Injury, this trial is ongoing. The trial is conducted by Minneapolis Veterans Affairs Medical Center and has accumulated 7 data snapshots since 2013. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Unknown EARLY_PHASE1
-
Sep 2024 — Present [monthly]
Unknown EARLY_PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Unknown EARLY_PHASE1
Status: Unknown Status → Unknown
-
Sep 2023 — Jul 2024 [monthly]
Unknown Status EARLY_PHASE1
Status: Active Not Recruiting → Unknown Status
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Sep 2021 — Sep 2023 [monthly]
Active Not Recruiting EARLY_PHASE1
▶ Show 2 earlier versions
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Jan 2021 — Sep 2021 [monthly]
Active Not Recruiting EARLY_PHASE1
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Jun 2019 — Jan 2021 [monthly]
Active Not Recruiting EARLY_PHASE1
First recorded
Aug 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Minneapolis Veterans Affairs Medical Center
For direct contact, visit the study record on ClinicalTrials.gov .