NCT04347785

Brief Summary

Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established. The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress77%
Jan 2011Dec 2030

Study Start

First participant enrolled

January 1, 2011

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

10 years

First QC Date

March 26, 2020

Last Update Submit

April 13, 2020

Conditions

Carotid Endarterectomy

Keywords

Carotid Stenosisregional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Stroke

    An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction.

    up to 5 years

Secondary Outcomes (1)

  • Clavien-Dindo Classification >3

    30 days

Other Outcomes (1)

  • Major adverse cardiosvascular and cerebrovascular events

    up to 5 years

Study Arms (2)

Neurologic deficit

All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis who presented alterations in the neurologic examination after ICA clamping during CEA area selected

Procedure: carotid endarterectomy

control

The control patients are submitted to the same procedure but with no neurologic alterations, are consecutively selected. a 1 to 1 ratio is used

Procedure: carotid endarterectomy

Interventions

carotid endarterectomyPROCEDURE

shunt

Neurologic deficitcontrol

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post-clamping deficits were defined as any persistent alteration at neurologic examination during the CACC and resistant to hemodynamic adjustment

You may qualify if:

  • carotid endarterectomy under regional anesthesia
  • Postclamping carotid deficit

You may not qualify if:

  • carotid stenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina da Universidade do Porto

Porto, 4200 - 319, Portugal

RECRUITING

Related Publications (3)

  • Pereira-Macedo J, Rocha-Neves JP, Dias-Neto MF, Andrade JPV. Prognostic effect of troponin elevation in patients undergoing carotid endarterectomy with regional anesthesia - A prospective study. Int J Surg. 2019 Nov;71:66-71. doi: 10.1016/j.ijsu.2019.09.015. Epub 2019 Sep 19.

    PMID: 31542388RESULT

  • Vieira-Andrade JD, Rocha-Neves JP, Macedo JP, Dias-Neto MF. Onset of Neurological Deficit During Carotid Clamping With Carotid Endarterectomy Under Regional Anesthesia Is Not a Predictor of Carotid Restenosis. Ann Vasc Surg. 2019 Nov;61:193-202. doi: 10.1016/j.avsg.2019.05.025. Epub 2019 Aug 2.

    PMID: 31382007RESULT

  • Pereira-Macedo J, Duarte-Gamas L, Pereira-Neves A, de Andrade JJP, Rocha-Neves J. Short-term outcomes after selective shunt during carotid endarterectomy: a propensity score matching analysis. Neurocirugia (Engl Ed). 2024 Mar-Apr;35(2):71-78. doi: 10.1016/j.neucie.2023.07.006. Epub 2023 Sep 9.

    PMID: 37696419DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Joao P Rocha-Neves, MD, MSC; MPH, FEBVS

CONTACT

+351910486230joaorochaneves@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Angiology and Vascular Surgery, MD/MSc, MPH epidemiology, FEBVS

Study Record Dates

First Submitted

March 26, 2020

First Posted

April 15, 2020

Study Start

January 1, 2011

Primary Completion

December 31, 2020

Study Completion (Estimated)

December 31, 2030

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

PT(1)