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

Sponsor
Minneapolis Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT03956017
Collaborator
(none)
341
Enrollment
1
Location
2
Arms
108
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
341 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery
Actual Study Start Date :
Aug 5, 2013
Anticipated Primary Completion Date :
Aug 4, 2022
Anticipated Study Completion Date :
Aug 4, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. BNP levels following surgery [48 hours]

      Peak values

    2. Cardiac Troponin levels following surgery [48 hours]

      Peak values

    3. Change in Troponin levels from baseline to peak [48 hours]

      Change from baseline to peak

    4. Number of participants with adverse cardiac outcomes following surgery [48 hours]

      Myocardial Infarction (MI) and death

    Secondary Outcome Measures

    1. Number of participants who died [30 days]

      All cause mortality

    2. Number of participants requiring coronary revascularization [30 days]

      Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG)

    3. Number of participants with new heart failure [30 days]

      Heart failure, newly diagnosed by cardiologist

    4. Number of participants with new onset Atrial Fibrillation (A-Fib) [30 days]

      New onset A-Fib

    5. Number of participants with infection [30 days]

      Infection diagnosed by a primary care provider

    6. Number of participants with a surgical graft failure [30 days]

      Primary surgical site graft failure

    7. Length of stay [30 days]

      Length of stay in days for index hospitalization

    8. Rate of readmission at 1 year following discharge [1 year]

      Any admission to hospital for 1 year post discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • ELECTIVE HIGH RISK NON-CARDIAC SURGERY
    Exclusion Criteria:
    • REACTION TO COQ10

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Va Medical Center Minneapolis Minnesota United States 55417

    Sponsors and Collaborators

    • Minneapolis Veterans Affairs Medical Center

    Investigators

    • Study Chair: EDWARD MCFALLS, MD, SITE PI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edward McFalls, CARDIOLOGIST, Minneapolis Veterans Affairs Medical Center
    ClinicalTrials.gov Identifier:
    NCT03956017
    Other Study ID Numbers:
    • IND 119600 Coenzyme Q10
    First Posted:
    May 20, 2019
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ubiquinone
    Coenzyme Q10

    Study Results

    No Results Posted as of Aug 31, 2021