Myocardial InjuryEarly Phase 1ACENCT03956017
Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery
A Early Phase 1 study testing Ubiquinone in people with Myocardial Injury, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- Ubiquinone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2013to 4 Aug 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ELECTIVE HIGH RISK NON-CARDIAC SURGERY
Who cannot join
- REACTION TO COQ10
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myocardial Injury
- Being tested
- Ubiquinone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbiquinoneDrug
Also called CoQ10, Coenzyme Q10
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
PlaceboDrug
Also called Sugar pill, inactive substance
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
| Study group | Role | What they receive |
|---|---|---|
| Ubiquinone | Experimental | Take oral tablets as directed (2x200 mg for 3 days prior to surgery) Receives: Drug: Ubiquinone |
| Placebo | Placebo comparator | Take oral tablets as directed (2x200 mg for 3 days prior to surgery) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BNP levels following surgery
Peak values
Measured: 48 hours
Cardiac Troponin levels following surgery
Peak values
Measured: 48 hours
Change in Troponin levels from baseline to peak
Change from baseline to peak
Measured: 48 hours
Number of participants with adverse cardiac outcomes following surgery
Myocardial Infarction (MI) and death
Measured: 48 hours
Secondary outcomes (8)
Number of participants who died
All cause mortality
Measured: 30 days
Number of participants requiring coronary revascularization
Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG)
Measured: 30 days
Number of participants with new heart failure
Heart failure, newly diagnosed by cardiologist
Measured: 30 days
Number of participants with new onset Atrial Fibrillation (A-Fib)
New onset A-Fib
Measured: 30 days
Number of participants with infection
Infection diagnosed by a primary care provider
Measured: 30 days
Number of participants with a surgical graft failure
Primary surgical site graft failure
Measured: 30 days
Length of stay
Length of stay in days for index hospitalization
Measured: 30 days
Rate of readmission at 1 year following discharge
Any admission to hospital for 1 year post discharge
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start5 Aug 2013
- Primary completion4 Aug 2022 (estimated)
- Study completion4 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 341 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Edward McFalls, Minneapolis Veterans Affairs Medical Center
- Investigators
- EDWARD MCFALLS, MD, Study chair, SITE PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956017
- Sponsor's protocol ID
- IND 119600 Coenzyme Q10
- Acronym
- ACE
- Status last verified
- Aug 2021
- First submitted
- 16 May 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing plan will be left at the discretion of the VA funding organization and statistical site.
Publications
Khan A, Johnson DK, Carlson S, Hocum-Stone L, Kelly RF, Gravely AA, Mbai M, Green DL, Santilli S, Garcia S, Adabag S, McFalls EO. NT-Pro BNP Predicts Myocardial Injury Post-vascular Surgery and is Reduced with CoQ10: A Randomized Double-Blind Trial. Ann Vasc Surg. 2020 Apr;64:292-302. doi: 10.1016/j.avsg.2019.09.017. Epub 2019 Oct 17.
PubMed 31629852
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery
- ClinicalTrials.gov ID
- NCT03956017
- Acronym / sponsor ID
- ACE / IND 119600 Coenzyme Q10
- Conditions
- Myocardial Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 341 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- 5 Aug 2013 (actual)
- Primary completion
- 4 Aug 2022 (estimated)
- Study completion
- 4 Aug 2022 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ubiquinone | Experimental | Drug: UbiquinoneTake oral tablets as directed (2x200 mg for 3 days prior to surgery) |
| Placebo | Placebo comparator | Drug: PlaceboTake oral tablets as directed (2x200 mg for 3 days prior to surgery) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ELECTIVE HIGH RISK NON-CARDIAC SURGERY
Key exclusion criteria (1 listed)
- REACTION TO COQ10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UbiquinoneAlso: CoQ10, Coenzyme Q10Take oral tablets as directed (2x200 mg for 3 days prior to surgery) | Drug | Ubiquinone |
| PlaceboAlso: Sugar pill, inactive substanceTake oral tablets as directed (2x200 mg for 3 days prior to surgery) | Drug | Placebo |
Primary outcome
BNP levels following surgery
Time frame: 48 hours
Peak values
Cardiac Troponin levels following surgery
Time frame: 48 hours
Peak values
Change in Troponin levels from baseline to peak
Time frame: 48 hours
Change from baseline to peak
Number of participants with adverse cardiac outcomes following surgery
Time frame: 48 hours
Myocardial Infarction (MI) and death
8 secondary outcomes
Number of participants who died
Time frame: 30 days
Number of participants requiring coronary revascularization
Time frame: 30 days
Number of participants with new heart failure
Time frame: 30 days
Number of participants with new onset Atrial Fibrillation (A-Fib)
Time frame: 30 days
Number of participants with infection
Time frame: 30 days
Number of participants with a surgical graft failure
Time frame: 30 days
Length of stay
Time frame: 30 days
Rate of readmission at 1 year following discharge
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 31629852Khan A, Johnson DK, Carlson S, Hocum-Stone L, Kelly RF, Gravely AA, Mbai M, Green DL, Santilli S, Garcia S, Adabag S, McFalls EO. NT-Pro BNP Predicts Myocardial Injury Post-vascular Surgery and is Reduced with CoQ10: A Randomized Double-Blind Trial. Ann Vasc Surg. 2020 Apr;64:292-302. doi: 10.1016/j.avsg.2019.09.017. Epub 2019 Oct 17.
- Individual participant dataSharing planned: No. Sharing plan will be left at the discretion of the VA funding organization and statistical site.
Related trials for Myocardial Injury
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Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
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PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
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Not yet recruitingPhase 2
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EDWARD MCFALLS, MD study chair
SITE PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ubiquinone in people with Myocardial Injury, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BNP levels following surgery (time frame: 48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.