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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956017
Recruitment Status : Active, not recruiting
First Posted : May 20, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Edward McFalls, Minneapolis Veterans Affairs Medical Center

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
Myocardial Injury Drug: Ubiquinone Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 5, 2013
Estimated Primary Completion Date : August 4, 2021
Estimated Study Completion Date : August 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

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 Name: 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 Name: Sugar pill, inactive substance




Primary Outcome Measures :
  1. BNP levels following surgery [ Time Frame: 48 hours ]
    Peak values

  2. Cardiac Troponin levels following surgery [ Time Frame: 48 hours ]
    Peak values

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

  4. Number of participants with adverse cardiac outcomes following surgery [ Time Frame: 48 hours ]
    Myocardial Infarction (MI) and death


Secondary Outcome Measures :
  1. Number of participants who died [ Time Frame: 30 days ]
    All cause mortality

  2. Number of participants requiring coronary revascularization [ Time Frame: 30 days ]
    Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG)

  3. Number of participants with new heart failure [ Time Frame: 30 days ]
    Heart failure, newly diagnosed by cardiologist

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

  5. Number of participants with infection [ Time Frame: 30 days ]
    Infection diagnosed by a primary care provider

  6. Number of participants with a surgical graft failure [ Time Frame: 30 days ]
    Primary surgical site graft failure

  7. Length of stay [ Time Frame: 30 days ]
    Length of stay in days for index hospitalization

  8. Rate of readmission at 1 year following discharge [ Time Frame: 1 year ]
    Any admission to hospital for 1 year post discharge



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ELECTIVE HIGH RISK NON-CARDIAC SURGERY

Exclusion Criteria:

  • REACTION TO COQ10

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956017


Locations
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United States, Minnesota
Va Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
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Study Chair: EDWARD MCFALLS, MD SITE PI

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edward McFalls, CARDIOLOGIST, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03956017     History of Changes
Other Study ID Numbers: IND 119600 Coenzyme Q10
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing plan will be left at the discretion of the VA funding organization and statistical site.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ubiquinone
Antioxidants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents