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The Aortic Surgery Cerebral Protection Evaluation (ACE) Randomized CardioLink-3 Trial

Primary Purpose

Aortic Aneurysm, Thoracic

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Axillary artery cannulation
Innominate artery cannulation
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aortic Aneurysm, Thoracic focused on measuring antegrade cerebral perfusion, innominate artery cannulation, axillary artery cannulation, aortic surgery, deep hypothermic circulatory arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Elective aortic arch operation.
  3. Planned open distal anastamosis with deep hypothermic circulatory arrest.

Exclusion Criteria:

  1. Patients undergoing surgery for aortic dissection or urgent/emergent operation.
  2. Patients undergoing surgery for total aortic arch replacement.
  3. Patients who are unable to undergo MRI scan (such as due to claustrophobia).
  4. Use of an investigational drug or device at the time of enrolment
  5. Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes

Sites / Locations

  • London Health Sciences Centre
  • St Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Axillary artery cannulation

Innominate artery cannulation

Arm Description

Axillary artery cannulation for antegrade cerebral perfusion

Innominate artery cannulation for antegrade cerebral perfusion

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

all-cause mortality
Stroke or TIA (transient ischemic attack)
Neurocognitive dysfunction
Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE)
Number of new ischemic lesions
assessed by DW-MRI
Volume of new ischemic lesions
assessed by DW-MRI
Intracerebral hemorrhage
assessed by DW-MRI
S100B and Neuron Specific Enolase
Post-operative serum level of circulating biomarkers of neuronal injury
Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation
Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia

Full Information

First Posted
June 10, 2015
Last Updated
September 11, 2018
Sponsor
Unity Health Toronto
Collaborators
London Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02554032
Brief Title
The Aortic Surgery Cerebral Protection Evaluation (ACE) Randomized CardioLink-3 Trial
Official Title
A Randomized Controlled Trial of Axillary vs. Innominate Artery Cannulation for Antegrade Cerebral Protection in Aortic Surgery: The ACE Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
London Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracic
Keywords
antegrade cerebral perfusion, innominate artery cannulation, axillary artery cannulation, aortic surgery, deep hypothermic circulatory arrest

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Axillary artery cannulation
Arm Type
Active Comparator
Arm Description
Axillary artery cannulation for antegrade cerebral perfusion
Arm Title
Innominate artery cannulation
Arm Type
Active Comparator
Arm Description
Innominate artery cannulation for antegrade cerebral perfusion
Intervention Type
Procedure
Intervention Name(s)
Axillary artery cannulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Innominate artery cannulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
new severe ischemic lesions
Description
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.
Time Frame
Post-operative day 4
Title
Total operative time
Description
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.
Time Frame
Intra-operative
Secondary Outcome Measure Information:
Title
all-cause mortality
Time Frame
30-day
Title
Stroke or TIA (transient ischemic attack)
Time Frame
30-day
Title
Neurocognitive dysfunction
Description
Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE)
Time Frame
Post-operative day 4
Title
Number of new ischemic lesions
Description
assessed by DW-MRI
Time Frame
Post-operative day 4
Title
Volume of new ischemic lesions
Description
assessed by DW-MRI
Time Frame
Post-operative day 4
Title
Intracerebral hemorrhage
Description
assessed by DW-MRI
Time Frame
Post-operative day 4
Title
S100B and Neuron Specific Enolase
Description
Post-operative serum level of circulating biomarkers of neuronal injury
Time Frame
24 hours post-op
Title
Post-operative sepsis, delirium, seizure, encephalopathy, atrial fibrillation, post-operative myocardial infarction, re-operation
Time Frame
30-day
Title
Seroma, brachial plexus injury, reduced arm mobility and pain, arm ischemia
Time Frame
30-day
Other Pre-specified Outcome Measures:
Title
Cerebral oximetry desaturation
Time Frame
intra-operative
Title
CPB (cardiopulmonary bypass) time
Time Frame
intra-operative
Title
Deep hypothermic circulatory arrest time
Time Frame
intra-operative
Title
Antegrade cerebral perfusion time
Time Frame
intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mazer, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36315249
Citation
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.
Results Reference
derived
PubMed Identifier
33431219
Citation
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.
Results Reference
derived
PubMed Identifier
28601820
Citation
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.
Results Reference
derived

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The Aortic Surgery Cerebral Protection Evaluation (ACE) Randomized CardioLink-3 Trial

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