UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030428
Receipt number R000034743
Scientific Title The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery
Date of disclosure of the study information 2017/12/16
Last modified on 2022/01/23 18:03:23

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Basic information

Public title

The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery

Acronym

The development of and risk factor for postoperative cognitive dysfunction in cardiovascular surgery

Scientific Title

The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery

Scientific Title:Acronym

The development of and risk factor for postoperative cognitive dysfunction in cardiovascular surgery

Region

Japan


Condition

Condition

Patients for cardiovascular surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of the present study is to evaluate the incident rate and risk factors for development of postoperative cognitive dysfunction(POCD) in each type of cardiovascular surgery.

Basic objectives2

Others

Basic objectives -Others

This is the observational study for development of postoperative cognitive dysfunction in cardiovascular surgeries.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

POCD was defined as a 20% score or more reduction in at least two of the neuropsychological test. The evaluation of incident rate of POCD will performed in each different types of cardiovascular surgery

Key secondary outcomes

The association between the development of POCD and patients' background, humoral factors(blood concentration of symmetric dimethylarginine arginine,arginine,eicosapentaenoic acid,docosahexaenoic acid and arachidonic acid),intraoperative monitoring and factors, and postoperative factors will be evaluated.The daily life activity in 1 and 3 month postoperatively will be evaluated by questionnaire.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases of aortic valve replacement, transcatheter aortic valve implantation, mitral valve replacement or plasty, surgery for major aorta (open surgery, stent graft implantation) and off -pump CABG.

Key exclusion criteria

Cases with neurological disease, symptomatic cerebral infarction,impossible for performing neuropsychological test, acute phase of infective endocarditis, emergency case and without the evaluation of chest CT and brain MRI.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Kazuyoshi
Middle name
Last name Ishida

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

7558505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2291

Email

ishid002@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Kazuyoshi
Middle name
Last name Ishida

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

7558505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2291

Homepage URL


Email

ishid002@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB center Yamaguchi University Graduate School of Medicine

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan

Tel

0836-22-2428

Email

me223@yamaguchi-u.ac.jp


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

2017 Year 12 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://jsa-shoroku.jp/search/detail_program/id:2621

Number of participants that the trial has enrolled

300

Results

In 103 patients with aortic valve replacement, arteriosclerotic of ascending and descending aorta and carotid were risk factors for postoperative cognitive dysfunction (POCD).In 29 cases with aortic aneurysm surgery and 34 cases of other cardiac surgery, no association of blood concentration of ADMA, arginine, EPA and arachidonic acid with POCD were observed in these cases. In 91 cases of mitral valve surgery, mitral valve calcification was one of the risk factors for development of POCD.

Results date posted

2019 Year 06 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 06 Month 28 Day

Date of IRB

2017 Year 06 Month 28 Day

Anticipated trial start date

2017 Year 12 Month 16 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is a prospective observational study for evaluating the development of postoperative cognitive dysfunction (POCD) in cardiovascular surgery cases who admit to the Yamaguchi university hospital. POCD is evaluated 7-12 postoperatively and the associating factors of it including patients background, humoral factors, intraoperative factors, intraoperative monitoring values and postoperative factors will also be evaluated in each surgery. Daily life activity will also be evaluate 1 and 3month postoperatively by questionnaire.


Management information

Registered date

2017 Year 12 Month 16 Day

Last modified on

2022 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034743


Research Plan
Registered date File name
2022/01/23 術式別心臓大血管手術後高次脳機能障害に関する研究.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/01/23 高次機能UMIN提出.xlsx