UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024558
Receipt number R000028263
Scientific Title Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI
Date of disclosure of the study information 2016/12/01
Last modified on 2020/04/28 09:04:41

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Basic information

Public title

Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI

Acronym

Effect of recumbent positions on hemodynamics

Scientific Title

Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI

Scientific Title:Acronym

Effect of recumbent positions on hemodynamics

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Hepato-biliary-pancreatic medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the influence of left and right recumbent positions on hemodynamics in healthy adults.

Basic objectives2

Others

Basic objectives -Others

Not applicable

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in hemodynamics in supine, left recumbent and right recumbent positions.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

MRI study is performed once in supine, left recumbent and right recumbent positions.

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

No history of respiratory or cardiovascular diseases
Taking no regular medications

Key exclusion criteria

Obesity (BMI over 30)
Adults with claustrophobia
Pregnant adults
Adults under 20 of age

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Konosuke
Middle name
Last name Sasaki

Organization

Tohoku University Graduate School of Medicine

Division name

Cardiovasuclar surgery

Zip code

9818574

Address

1-1, Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7226

Email

konosuke.s@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Konosuke
Middle name
Last name Sasaki

Organization

Tohoku University Graduate School of Medicine

Division name

Cardiovasuclar surgery

Zip code

9818574

Address

1-1, Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7226

Homepage URL


Email

konosuke.s@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

North Japan Academy of Nursing Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University School of Medicine, IRB

Address

1-1, Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2016 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

12

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Under analysis

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

No longer recruiting

Date of protocol fixation

2017 Year 05 Month 01 Day

Date of IRB

2016 Year 10 Month 24 Day

Anticipated trial start date

2017 Year 06 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 25 Day

Last modified on

2020 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028263


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name