Carotid Artery DiseasesNCT04901000
Outcome of LA Versus GA for Staged CEA Prior To CABG
An observational study of Carotid Artery Diseases and Coronary Artery Disease, run by Thomas Aherne.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Artery Diseases, Coronary Artery Disease, Stroke
- What is being tested?
- Carotid endarterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2011to 30 Sep 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In-hospital patients referred by Cardiothoracic for carotid endarterectomy prior to CABG.
Who may be able to join
- All patients that had carotid endarterectomy performed in staged fashion within 6 months before a CABG operation.
Who cannot join
- Patients diagnosed with symptomatic carotid disease
About this study
Official title: Outcome of Local Versus General Anesthetic for Staged Carotid Endarterectomy Prior To CABG, Cohort Study
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).
Read the detailed description
The primary outcome was the rate of postoperative stroke in patients that had staged CEA prior to CABG. This was defined as CEA within a period of 4 weeks prior to CABG.
We retrospectively looked at those patients that fulfilled the inclusion criteria and had CEA performed either under LA (Group A) or under GA (Group B). We measured the 30 days' postoperative stroke rate as the main outcome. We also looked at the rate of intraoperative stroke.
Additionally, we assessed the rate for developing nerve injuries and/or hematoma postoperatively. Finally, we examined the risk for developing postoperative stroke in patients with bilateral significant carotid artery disease that underwent surgery in one side.
- Conditions
- Carotid Artery Diseases, Coronary Artery Disease, Stroke
- Being tested
- Carotid endarterectomy
- Medical subject headings
- Carotid Artery Diseases, Coronary Artery Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomyProcedure or surgery
Carotid endarterectomy prior to CABG operations either under Local Anaesthetic or under General Anaesthetic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
a transient ischaemic attack (TIA), or a disabling stroke within 30 days of the carotid endarterectomy procedure.
Measured: 30 days
Secondary outcomes (3)
Major bleeding
Major haematoma was defined as a significant bleeding that required the patient to go back to theatre for a secondary procedure.
Measured: 30 days
Minor bleeding
A minor hematoma was defined as bleeding that resulted in bruising and neck swelling without causing significant concerns to require a secondary procedur
Measured: 30 days
Nerve injuries
Either neuropraxia that resolved with time or permanent injuries that resulted in disability.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Oct 2011
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Aherne
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham
- Responsible party
- Sponsor-investigator, Thomas Aherne, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901000
- Sponsor's protocol ID
- University Hospital Birmingham
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Hospital records not to be shared, but raw data used for statistical analysis will be shared after removing identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Local Versus General Anesthetic for Staged Carotid Endarterectomy Prior To CABG, Cohort Study
- ClinicalTrials.gov ID
- NCT04901000
- Acronym / sponsor ID
- University Hospital Birmingham
- Conditions
- Carotid Artery Diseases, Coronary Artery Disease, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Thomas AherneUniversity, hospital or other
- Collaborators
- University Hospital Birmingham
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 25 May 2021 (actual)
- 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.
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).
Detailed description
The primary outcome was the rate of postoperative stroke in patients that had staged CEA prior to CABG. This was defined as CEA within a period of 4 weeks prior to CABG.
We retrospectively looked at those patients that fulfilled the inclusion criteria and had CEA performed either under LA (Group A) or under GA (Group B). We measured the 30 days' postoperative stroke rate as the main outcome. We also looked at the rate of intraoperative stroke.
Additionally, we assessed the rate for developing nerve injuries and/or hematoma postoperatively. Finally, we examined the risk for developing postoperative stroke in patients with bilateral significant carotid artery disease that underwent surgery in one side.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid Endarterectomy under Local Anaesthetic Pre-CABG | – | Procedure: Carotid endarterectomyPatients that underwent carotid endarterectomy under local anaesthetic prior to coronary artery bypass operations in staged fashion within 6 months. |
| Carotid Endarterectomy under General Anaesthetic Pre-CABG | – | Procedure: Carotid endarterectomyPatients that underwent carotid endarterectomy under general anaesthetic prior to coronary artery bypass operations in staged fashion within 6 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In-hospital patients referred by Cardiothoracic for carotid endarterectomy prior to CABG.
Key inclusion criteria (1 listed)
- All patients that had carotid endarterectomy performed in staged fashion within 6 months before a CABG operation.
Key exclusion criteria (1 listed)
- Patients diagnosed with symptomatic carotid disease
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 |
|---|---|---|
| Carotid endarterectomyCarotid endarterectomy prior to CABG operations either under Local Anaesthetic or under General Anaesthetic. | Procedure or surgery | Carotid Endarterectomy under General Anaesthetic Pre-CABG, Carotid Endarterectomy under Local Anaesthetic Pre-CABG |
Primary outcome
Stroke
Time frame: 30 days
a transient ischaemic attack (TIA), or a disabling stroke within 30 days of the carotid endarterectomy procedure.
3 secondary outcomes
Major bleeding
Time frame: 30 days
Minor bleeding
Time frame: 30 days
Nerve injuries
Time frame: 30 days
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 25 May 2021.
- Individual participant dataSharing planned: Undecided. Hospital records not to be shared, but raw data used for statistical analysis will be shared after removing identifiers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases and Coronary Artery Disease, run by Thomas Aherne.
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 1 inclusion and 1 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Stroke (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2021.