- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554032
The Aortic Surgery Cerebral Protection Evaluation (ACE) Randomized CardioLink-3 Trial
September 11, 2018 updated by: Unity Health Toronto
A Randomized Controlled Trial of Axillary vs. Innominate Artery Cannulation for Antegrade Cerebral Protection in Aortic Surgery: The ACE Randomized Trial
The ACE trial is a multicentre, randomized controlled trial comparing axillary vs. innominate artery cannulation for established antegrade cerebral perfusion in patients having aortic surgery (thoracic and aortic arch) requiring deep hypothermic circulatory arrest using a non-inferiority trial design.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Surgery on the thoracic aorta often requires a brief period of deep hypothermic circulatory arrest (DHCA).
The most feared complication of aortic surgery is neurological injury, which can range from mild cognitive impairment to more severe injuries such as stroke.
Due to the significant morbidity and mortality associated with post-operative stroke and neurological dysfunction, cerebral protection techniques have evolved extensively.
A recommended approach to cerebral protection during DHCA is to deliver blood to the brain in an antegrade fashion via the arterial system, so called antegrade cerebral perfusion (ACP).
Axillary artery cannulation, a form of ACP, has become the preferred method of neuroprotection for aortic operations requiring DHCA.
However, axillary artery cannulation requires more surgical time and presents potential complications such as brachial plexus injury, seromas, and limb ischemia.
The present study aims to determine whether a less common alternative strategy, innominate artery cannulation, offers similar neuroprotection compared to axillary artery cannulation and reduces operative times.
A total of 110 patients undergoing elective aortic surgery will be randomly assigned to one of the two strategies.
The primary outcome will be the number of patients with new ischemic lesions found on post-operative diffusion weighted MRI (DW-MRI) and total operative time.
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
-
Toronto, Ontario, Canada, M5B1W8
- St Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Elective aortic arch operation.
- Planned open distal anastamosis with deep hypothermic circulatory arrest.
Exclusion Criteria:
- Patients undergoing surgery for aortic dissection or urgent/emergent operation.
- Patients undergoing surgery for total aortic arch replacement.
- Patients who are unable to undergo MRI scan (such as due to claustrophobia).
- Use of an investigational drug or device at the time of enrolment
- Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Axillary artery cannulation
Axillary artery cannulation for antegrade cerebral perfusion
|
The right axillary artery will be exposed via an infraclavicular incision and a Dacron graft sewn to it in an end to side fashion after 5000 units of IV heparin.
Following median sternotomy and full systemic heparinization, CPB will be initiated and the patient cooled.
The base of the innominate artery will be clamped, and antegrade cerebral perfusion will be provided via the axillary artery.
Following completion of the distal open aortic anastomosis, the clamp on the innominate artery will be removed, CPB via the aorta will be resumed and the patient will be rewarmed.
After completion of surgery and weaning from CPB, the axillary artery graft will then be removed, the artery repaired and the skin will be closed.
|
Active Comparator: Innominate artery cannulation
Innominate artery cannulation for antegrade cerebral perfusion
|
After median sternotomy, systemic heparinization, cannulation of the ascending aorta and right atrium, CPB and systemic cooling will be initiated.
The ascending aorta, proximal arch and the base of the innominate artery will be mobilized.
Purse-string sutures are placed on the anterior wall of the proximal innominate artery and a pediatric venous cannula inserted using a J wire and sequential dilatation.
Circulatory arrest with ACP is provided by clamping the base of the innominate artery and connecting the afferent limb of the CPB circuit to the innominate cannula.
Once the distal aortic anastomosis is completed, ACP is discontinued, and full CPB via the aortic graft is resumed.
Rewarming and the remaining surgery are then completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
new severe ischemic lesions
Time Frame: Post-operative day 4
|
The primary safety endpoint of this trial is the proportion of patients with new severe ischemic lesions found on post-operative DW-MRI compared with pre-operative MRI.
|
Post-operative day 4
|
Total operative time
Time Frame: Intra-operative
|
The primary efficacy endpoint of this trial is the difference in total operative time between the innominate artery cannulation group and the axillary artery cannulation group.
|
Intra-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all-cause mortality
Time Frame: 30-day
|
30-day
|
|
Stroke or TIA (transient ischemic attack)
Time Frame: 30-day
|
30-day
|
|
Neurocognitive dysfunction
Time Frame: Post-operative day 4
|
Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE)
|
Post-operative day 4
|
Number of new ischemic lesions
Time Frame: Post-operative day 4
|
assessed by DW-MRI
|
Post-operative day 4
|
Volume of new ischemic lesions
Time Frame: Post-operative day 4
|
assessed by DW-MRI
|
Post-operative day 4
|
Intracerebral hemorrhage
Time Frame: Post-operative day 4
|
assessed by DW-MRI
|
Post-operative day 4
|
S100B and Neuron Specific Enolase
Time Frame: 24 hours post-op
|
Post-operative serum level of circulating biomarkers of neuronal injury
|
24 hours post-op
|
Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation
Time Frame: 30-day
|
30-day
|
|
Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia
Time Frame: 30-day
|
30-day
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cerebral oximetry desaturation
Time Frame: intra-operative
|
intra-operative
|
CPB (cardiopulmonary bypass) time
Time Frame: intra-operative
|
intra-operative
|
Deep hypothermic circulatory arrest time
Time Frame: intra-operative
|
intra-operative
|
Antegrade cerebral perfusion time
Time Frame: intra-operative
|
intra-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Mazer, MD, Unity Health Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chen CH, Peterson MD, Mazer CD, Hibino M, Beaudin AE, Chu MWA, Dagenais F, Teoh H, Quan A, Dickson J, Verma S, Smith EE. Acute Infarcts on Brain MRI Following Aortic Arch Repair With Circulatory Arrest: Insights From the ACE CardioLink-3 Randomized Trial. Stroke. 2022 Oct 31. doi: 10.1161/STROKEAHA.122.041612. Online ahead of print.
- Peterson MD, Garg V, Mazer CD, Chu MWA, Bozinovski J, Dagenais F, MacArthur RGG, Ouzounian M, Quan A, Juni P, Bhatt DL, Marotta TR, Dickson J, Teoh H, Zuo F, Smith EE, Verma S; ACE CardioLink-3 Trial Working Group. A randomized trial comparing axillary versus innominate artery cannulation for aortic arch surgery. J Thorac Cardiovasc Surg. 2022 Nov;164(5):1426-1438.e2. doi: 10.1016/j.jtcvs.2020.10.152. Epub 2020 Dec 1.
- Garg V, Peterson MD, Chu MW, Ouzounian M, MacArthur RG, Bozinovski J, El-Hamamsy I, Victor Chu F, Garg A, Hall J, Thorpe KE, Dhingra N, Teoh H, Marotta TR, Latter DA, Quan A, Mamdani M, Juni P, David Mazer C, Verma S. Axillary versus innominate artery cannulation for antegrade cerebral perfusion in aortic surgery: design of the Aortic Surgery Cerebral Protection Evaluation (ACE) CardioLink-3 randomised trial. BMJ Open. 2017 Jun 10;7(6):e014491. doi: 10.1136/bmjopen-2016-014491.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
June 10, 2015
First Submitted That Met QC Criteria
September 17, 2015
First Posted (Estimate)
September 18, 2015
Study Record Updates
Last Update Posted (Actual)
September 13, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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