NCT02554032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

3.1 years

First QC Date

June 10, 2015

Last Update Submit

September 11, 2018

Conditions

Aortic Aneurysm, Thoracic

Keywords

antegrade cerebral perfusioninnominate artery cannulationaxillary artery cannulationaortic surgerydeep hypothermic circulatory arrest

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Intra-operative

Secondary Outcomes (9)

  • all-cause mortality

    30-day

  • Stroke or TIA (transient ischemic attack)

    30-day

  • Neurocognitive dysfunction

    Post-operative day 4

  • Number of new ischemic lesions

    Post-operative day 4

  • Volume of new ischemic lesions

    Post-operative day 4

  • +4 more secondary outcomes

Other Outcomes (4)

  • Cerebral oximetry desaturation

    intra-operative

  • CPB (cardiopulmonary bypass) time

    intra-operative

  • Deep hypothermic circulatory arrest time

    intra-operative

  • +1 more other outcomes

Study Arms (2)

Axillary artery cannulation

ACTIVE COMPARATOR

Axillary artery cannulation for antegrade cerebral perfusion

Procedure: Axillary artery cannulation

Innominate artery cannulation

ACTIVE COMPARATOR

Innominate artery cannulation for antegrade cerebral perfusion

Procedure: Innominate artery cannulation

Interventions

Axillary artery cannulationPROCEDURE

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.

Axillary artery cannulation
Innominate artery cannulationPROCEDURE

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.

Innominate artery cannulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (3)

  • 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.

    PMID: 36315249DERIVED

  • 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.

    PMID: 33431219DERIVED

  • 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.

    PMID: 28601820DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • David Mazer, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

September 18, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

CA(2)