UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between preoperative cardiac function and cardiac insufficiency after carotid endarterectomy
Title of the study (Brief title)	Association between preoperative cardiac function and cardiac insufficiency after carotid endarterectomy
Region	Japan

Condition
Condition	carotid artery stenosis
Classification by specialty	Anesthesiology Neurosurgery Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	revealing the association between preoperative cardiac function and cardiac insufficiency after carotid endarterectomy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	morbidity of cardiac insufficiency after carotid endarterectomy
Key secondary outcomes	assessment of preoperative cardiac function

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	86 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient undergone carotid endarterectomy under general anesthesia
Key exclusion criteria	emergency operation dialysis patient
Target sample size	80

Research contact person
Name of lead principal investigator	Yamaura Ken
Organization	Fukuoka University School of Medicine
Division name	Department of Anesthesiology
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Email	keny@fukuoka-u.ac.jp

Public contact
Name of contact person	Shigematsu Kenji
Organization	Fukuoka University Hospital
Division name	Operation Department
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Homepage URL
Email	kshige@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Fukuoka University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	retrospective study from 2013 to 2015

Management information
Registered date	2016 Year 03 Month 22 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024871