Aortic Aneurysm, ThoracicNCT02554032
The Aortic Surgery Cerebral Protection Evaluation (ACE) Randomized CardioLink-3 Trial
A study testing Axillary artery cannulation and Innominate artery cannulation in people with Aortic Aneurysm, Thoracic, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- Axillary artery cannulation and Innominate artery cannulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2015to Jul 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Elective aortic arch operation.
- Planned open distal anastamosis with deep hypothermic circulatory arrest.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
London Health Sciences Centre
London, Ontario, N6A 5W9
St Michael's Hospital
Toronto, Ontario, M5B1W8
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- Axillary artery cannulation, Innominate artery cannulation
- Keywords
- antegrade cerebral perfusion, innominate artery cannulation, axillary artery cannulation, aortic surgery, deep hypothermic circulatory arrest
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary artery cannulationProcedure or surgery
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.
Innominate artery cannulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Axillary artery cannulation | Active comparator | Axillary artery cannulation for antegrade cerebral perfusion Receives: Procedure: Axillary artery cannulation |
| Innominate artery cannulation | Active comparator | Innominate artery cannulation for antegrade cerebral perfusion Receives: Procedure: Innominate artery cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
new severe ischemic lesions
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.
Measured: Post-operative day 4
Total operative time
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.
Measured: Intra-operative
Secondary outcomes (9)
all-cause mortality
Measured: 30-day
Stroke or TIA (transient ischemic attack)
Measured: 30-day
Neurocognitive dysfunction
Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE)
Measured: Post-operative day 4
Number of new ischemic lesions
assessed by DW-MRI
Measured: Post-operative day 4
Volume of new ischemic lesions
assessed by DW-MRI
Measured: Post-operative day 4
Intracerebral hemorrhage
assessed by DW-MRI
Measured: Post-operative day 4
S100B and Neuron Specific Enolase
Post-operative serum level of circulating biomarkers of neuronal injury
Measured: 24 hours post-op
Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation
Measured: 30-day
Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- David Mazer, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554032
- Sponsor's protocol ID
- 15-071
- Status last verified
- Sep 2018
- First submitted
- 10 Jun 2015
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
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. 2023 Jan;54(1):67-77. doi: 10.1161/STROKEAHA.122.041612. Epub 2022 Oct 31.
PubMed 36315249Peterson 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.
PubMed 33431219Garg 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.
PubMed 28601820
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Axillary vs. Innominate Artery Cannulation for Antegrade Cerebral Protection in Aortic Surgery: The ACE Randomized Trial
- ClinicalTrials.gov ID
- NCT02554032
- Acronym / sponsor ID
- 15-071
- Conditions
- Aortic Aneurysm, Thoracic
- Keywords
- antegrade cerebral perfusion, innominate artery cannulation, axillary artery cannulation, aortic surgery, deep hypothermic circulatory arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- Jun 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary artery cannulation | Active comparator | Procedure: Axillary artery cannulationAxillary artery cannulation for antegrade cerebral perfusion |
| Innominate artery cannulation | Active comparator | Procedure: Innominate artery cannulationInnominate artery cannulation for antegrade cerebral perfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Elective aortic arch operation.
- Planned open distal anastamosis with deep hypothermic circulatory arrest.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Axillary artery cannulationThe 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. | Procedure or surgery | Axillary artery cannulation |
| Innominate artery cannulationAfter 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. | Procedure or surgery | Innominate artery cannulation |
Primary outcome
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.
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.
9 secondary outcomes
all-cause mortality
Time frame: 30-day
Stroke or TIA (transient ischemic attack)
Time frame: 30-day
Neurocognitive dysfunction
Time frame: Post-operative day 4
Number of new ischemic lesions
Time frame: Post-operative day 4
Volume of new ischemic lesions
Time frame: Post-operative day 4
Intracerebral hemorrhage
Time frame: Post-operative day 4
S100B and Neuron Specific Enolase
Time frame: 24 hours post-op
Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation
Time frame: 30-day
Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia
Time frame: 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Derived from this study: PubMed 36315249Chen 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. 2023 Jan;54(1):67-77. doi: 10.1161/STROKEAHA.122.041612. Epub 2022 Oct 31.
- Derived from this study: PubMed 33431219Peterson 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.
- Derived from this study: PubMed 28601820Garg 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.
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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.
David Mazer, MD principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary artery cannulation and Innominate artery cannulation in people with Aortic Aneurysm, Thoracic, run by Unity Health Toronto at 2 sites in Canada.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
new severe ischemic lesions (time frame: Post-operative day 4). The study lists 2 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 NCT02554032, which also lists 3 linked publications.
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 13 Sep 2018.