NCT03596229

Brief Summary

Carotid endarterectomy is the operation for curing the significant carotid artery stenotic patients who are also at high cardiac risk. This retrospective study is to find out the incidence and risk factors related.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 5, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

July 5, 2018

Last Update Submit

January 17, 2020

Conditions

Carotid StenosisCarotid EndarterectomyAdverse Cardiac Events

Keywords

carotid endarterectomyadverse cardiac events

Outcome Measures

Primary Outcomes (1)

  • Incidence of major adverse cardiac events after carotid endarterectomy

    Major adverse cardiac event included myocardial infarction, significant arrhythmia, heart failure and cardiac arrest

    7 days

Secondary Outcomes (2)

  • associate factors with adverse cardiac event

    7 days

  • other adverse events

    7 days

Eligibility Criteria

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

The carotid stenotic patents scheduled for carotid endarterectomy

You may qualify if:

  • Every patients undergoing carotid endarterectomy in Siriraj hospital

You may not qualify if:

  • Patients with other simultaneous surgery with carotid endarterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 1. Mutirangura P et al. J Med Assoc Thai 2016; 99 (7): 785-93. 2. Boulanger M et al. Stroke. 2015 Oct;46(10):2843-8. 3. McKee PA et al. N Engl J Med. 1971 Dec 23;285(26):1441-6. 4.Go C et al. Ann Vasc Surg. 2015 Aug;29(6):1265-71. 5.Steinvil A et al. J Am Coll Cardiol. 2011 Feb 15;57(7):779-83. 6.Hoffmann R et al. Heart. 2005 Nov;91(11):1438-41. 7.Sposato LA et al. Journal of the Neurological Sciences. 2011 Oct 15;309(1-2):5-8. 8.Aboyans V et al. Eur Heart J. 2018 Mar 1;39(9):763-816. 9.Varon J, Marik PE. Vasc Health Risk Manag. 2008 Jun; 4(3): 615-627. 10.Landesberg G et al. Circulation. 2009;119:2936-2944

    RESULT

MeSH Terms

Conditions

Carotid StenosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Aphichat Suphathamwit, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 23, 2018

Study Start

October 1, 2018

Primary Completion

November 30, 2019

Study Completion

January 15, 2020

Last Updated

January 21, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)