NCT03788980

Brief Summary

This study may determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Medical records will be accessed to find any information pertaining to postoperative complications. Additionally, it may determine the cognitive dysfunction of patients undergoing CEA, assessed by Mini Mental Status Examination (MMSE).

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
2 countries

2 active sites

Status
terminated

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

April 13, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

December 26, 2018

Last Update Submit

September 29, 2023

Conditions

Postoperative ComplicationsPostoperative Cognitive Dysfunction

Keywords

Endarterectomy

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    Incidence of postoperative complications and identify the associated risk factors.

    30 days

Secondary Outcomes (1)

  • Cognitive Dysfunction

    30 days

Study Arms (1)

carotid endarterectomy group

patients undergoing carotid endarterectomy

Procedure: Carotid endarterectomyDiagnostic Test: Mini Mental Status Examination

Interventions

Carotid endarterectomyPROCEDURE

Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)

Also known as: CAE
carotid endarterectomy group
Mini Mental Status ExaminationDIAGNOSTIC_TEST

Short questionnaire used to diagnose cognitive dysfunction

Also known as: MMSE
carotid endarterectomy group

Eligibility Criteria

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

Patients 18 years of age or older scheduled to undergo carotid endarterectomy

You may qualify if:

  • Patients males or females, 18 years of age and older
  • Scheduled to undergo Carotid Endarterectomy

You may not qualify if:

  • Pregnant women
  • Incarcerated individuals
  • Patients not able to consent for themselves
  • Any disease or condition deemed by the investigator to disqualify the patient
  • Participating in any interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Related Publications (16)

  • Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995 May 10;273(18):1421-8.

    PMID: 7723155BACKGROUND

  • Stoneham MD, Thompson JP. Arterial pressure management and carotid endarterectomy. Br J Anaesth. 2009 Apr;102(4):442-52. doi: 10.1093/bja/aep012. Epub 2009 Feb 20.

    PMID: 19233880BACKGROUND

  • McCollum PT, da Silva A, Ridler BD, de Cossart L. Carotid endarterectomy in the U.K. and Ireland: audit of 30-day outcome. The Audit Committee for the Vascular Surgical Society. Eur J Vasc Endovasc Surg. 1997 Nov;14(5):386-91. doi: 10.1016/s1078-5884(97)80289-4.

    PMID: 9413380BACKGROUND

  • Ferguson GG, Eliasziw M, Barr HW, Clagett GP, Barnes RW, Wallace MC, Taylor DW, Haynes RB, Finan JW, Hachinski VC, Barnett HJ. The North American Symptomatic Carotid Endarterectomy Trial : surgical results in 1415 patients. Stroke. 1999 Sep;30(9):1751-8. doi: 10.1161/01.str.30.9.1751.

    PMID: 10471419BACKGROUND

  • Robinson TG, James M, Youde J, Panerai R, Potter J. Cardiac baroreceptor sensitivity is impaired after acute stroke. Stroke. 1997 Sep;28(9):1671-6. doi: 10.1161/01.str.28.9.1671.

    PMID: 9303008BACKGROUND

  • Rothwell PM, Giles MF, Chandratheva A, Marquardt L, Geraghty O, Redgrave JN, Lovelock CE, Binney LE, Bull LM, Cuthbertson FC, Welch SJ, Bosch S, Alexander FC, Silver LE, Gutnikov SA, Mehta Z; Early use of Existing Preventive Strategies for Stroke (EXPRESS) study. Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison. Lancet. 2007 Oct 20;370(9596):1432-42. doi: 10.1016/S0140-6736(07)61448-2.

    PMID: 17928046BACKGROUND

  • Asiddao CB, Donegan JH, Whitesell RC, Kalbfleisch JH. Factors associated with perioperative complications during carotid endarterectomy. Anesth Analg. 1982 Aug;61(8):631-7.

    PMID: 7201265BACKGROUND

  • Kunkel JM, Gomez ER, Spebar MJ, Delgado RJ, Jarstfer BS, Collins GJ. Wound hematomas after carotid endarterectomy. Am J Surg. 1984 Dec;148(6):844-7. doi: 10.1016/0002-9610(84)90451-3.

    PMID: 6507761BACKGROUND

  • Karapanayiotides T, Meuli R, Devuyst G, Piechowski-Jozwiak B, Dewarrat A, Ruchat P, Von Segesser L, Bogousslavsky J. Postcarotid endarterectomy hyperperfusion or reperfusion syndrome. Stroke. 2005 Jan;36(1):21-6. doi: 10.1161/01.STR.0000149946.86087.e5. Epub 2004 Dec 2.

    PMID: 15576656BACKGROUND

  • Naylor AR, Evans J, Thompson MM, London NJ, Abbott RJ, Cherryman G, Bell PR. Seizures after carotid endarterectomy: hyperperfusion, dysautoregulation or hypertensive encephalopathy? Eur J Vasc Endovasc Surg. 2003 Jul;26(1):39-44. doi: 10.1053/ejvs.2002.1925.

    PMID: 12819646BACKGROUND

  • Russell DA, Gough MJ. Intracerebral haemorrhage following carotid endarterectomy. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):115-23. doi: 10.1016/j.ejvs.2004.03.020.

    PMID: 15234690BACKGROUND

  • Nordlander M, Sjoquist PO, Ericsson H, Ryden L. Pharmacodynamic, pharmacokinetic and clinical effects of clevidipine, an ultrashort-acting calcium antagonist for rapid blood pressure control. Cardiovasc Drug Rev. 2004 Fall;22(3):227-50. doi: 10.1111/j.1527-3466.2004.tb00143.x.

    PMID: 15492770BACKGROUND

  • Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.

    PMID: 18806012BACKGROUND

  • Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, Newman MF, Corwin HL; ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008 Jul;107(1):59-67. doi: 10.1213/ane.0b013e3181732e53.

    PMID: 18635468BACKGROUND

  • Ericsson H, Bredberg U, Eriksson U, Jolin-Mellgard A, Nordlander M, Regardh CG. Pharmacokinetics and arteriovenous differences in clevidipine concentration following a short- and a long-term intravenous infusion in healthy volunteers. Anesthesiology. 2000 Apr;92(4):993-1001. doi: 10.1097/00000542-200004000-00016.

    PMID: 10754618BACKGROUND

  • Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.

    PMID: 23043910BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsPostoperative Cognitive Complications

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Sergio Bergese, MD

    The Ohio State University Wexner Medical Center Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2018

First Posted

December 28, 2018

Study Start

April 13, 2018

Primary Completion

July 9, 2019

Study Completion

July 9, 2019

Last Updated

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

The de-identified date from the international site and the data collected at the main site will be analyzed at The Ohio State University Wexner Medical Center.

Locations

ES(1)US(1)