An Early Phase 1 interventional study of Ubiquinone and Placebo in Myocardial Injury, sponsored by Minneapolis Veterans Affairs Medical Center. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by Minneapolis Veterans Affairs Medical Center · Early Phase 1, Interventional, and Treatment
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.
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.
4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's planned enrollment of 341 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Minneapolis Veterans Affairs Medical Center is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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)
Drug: Placebo
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
Also known as: CoQ10, Coenzyme Q10
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
Also known as: Sugar pill, inactive substance
BNP levels following surgery
Peak values
Time frame: 48 hours
Cardiac Troponin levels following surgery
Peak values
Time frame: 48 hours
Change in Troponin levels from baseline to peak
Change from baseline to peak
Time frame: 48 hours
Number of participants with adverse cardiac outcomes following surgery
Myocardial Infarction (MI) and death
Time frame: 48 hours
Number of participants who died
All cause mortality
Time frame: 30 days
Number of participants requiring coronary revascularization
Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG)
Time frame: 30 days
Number of participants with new heart failure
Heart failure, newly diagnosed by cardiologist
Time frame: 30 days
Number of participants with new onset Atrial Fibrillation (A-Fib)
New onset A-Fib
Time frame: 30 days
Number of participants with infection
Infection diagnosed by a primary care provider
Time frame: 30 days
Number of participants with a surgical graft failure
Primary surgical site graft failure
Time frame: 30 days
Length of stay
Length of stay in days for index hospitalization
Time frame: 30 days
Rate of readmission at 1 year following discharge
Any admission to hospital for 1 year post discharge
Time frame: 1 year
Plan to share: No — Sharing plan will be left at the discretion of the VA funding organization and statistical site.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Minneapolis Veterans Affairs Medical Center