NCT04901000

Brief Summary

A retrospective analysis of all patients that underwent carotid endarterectomy (CEA) for stenotic disease - diagnosed at pre-operative investigation - prior to CABG as staged operation within 6- months. The rate of postoperative stroke and complications was compared between CEA performed under Local anaesthetic (LA) to those performed under General anaesthetic (GA).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

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

October 1, 2011

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

7 years

First QC Date

May 20, 2021

Last Update Submit

May 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stroke

    a transient ischaemic attack (TIA), or a disabling stroke within 30 days of the carotid endarterectomy procedure.

    30 days

Secondary Outcomes (3)

  • Major bleeding

    30 days

  • Minor bleeding

    30 days

  • Nerve injuries

    30 days

Study Arms (2)

Carotid Endarterectomy under Local Anaesthetic Pre-CABG

Patients that underwent carotid endarterectomy under local anaesthetic prior to coronary artery bypass operations in staged fashion within 6 months.

Procedure: Carotid endarterectomy

Carotid Endarterectomy under General Anaesthetic Pre-CABG

Patients that underwent carotid endarterectomy under general anaesthetic prior to coronary artery bypass operations in staged fashion within 6 months.

Procedure: Carotid endarterectomy

Interventions

Carotid endarterectomy prior to CABG operations either under Local Anaesthetic or under General Anaesthetic.

Carotid Endarterectomy under General Anaesthetic Pre-CABGCarotid Endarterectomy under Local Anaesthetic Pre-CABG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In-hospital patients referred by Cardiothoracic for carotid endarterectomy prior to CABG.

You may qualify if:

  • \- All patients that had carotid endarterectomy performed in staged fashion within 6 months before a CABG operation.

You may not qualify if:

  • Patients diagnosed with symptomatic carotid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carotid Artery DiseasesCoronary Artery DiseaseStroke

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Site Investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

October 1, 2011

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

May 25, 2021

Record last verified: 2021-05