UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002689
Receipt number R000003284
Scientific Title Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Date of disclosure of the study information 2009/10/30
Last modified on 2009/10/29 20:09:28

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Basic information

Public title

Evaluation of pulmonary circulation dynamics by using CT perfusion technique.

Acronym

Evaluation of pulmonary circulation dynamics by using CT perfusion technique.

Scientific Title

Evaluation of pulmonary circulation dynamics by using CT perfusion technique.

Scientific Title:Acronym

Evaluation of pulmonary circulation dynamics by using CT perfusion technique.

Region

Japan


Condition

Condition

pulmonary hypertension

Classification by specialty

Pneumology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Less invasively evaluating pulmonary circulation dynamics in pulmonary hypertension by using CT perfusion technique.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation between estimated pulmonary arterial pressure by CT perfusion and directly measured pulmonary arterial pressure

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

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

CT perfusion study by contrast enhancement

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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient with pulmonary hypertension or presumed case

Key exclusion criteria

Children younger than 15 years old
Contraindication of contrast enhanced CT such as severe renal dysfunction or history of allergy for contrast agent, etc.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumikazu Sakai

Organization

Saitama Medical University International Medical Center

Division name

Department of Diagnostic Radiology

Zip code


Address

1397-1, Yamane, Hidaka, Saitama

TEL

042-984-4520

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takeyuki Watadani

Organization

Saitama Medical University International Medical Center

Division name

Department of Diagnostic Radiology

Zip code


Address

1397-1, Yamane, Hidaka, Saitama

TEL

042-984-4520

Homepage URL


Email

watadani@saitama-med.ac.jp


Sponsor or person

Institute

Department of Diagnostic Radiology, Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

Nothing

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


Address


Tel


Email



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

埼玉医科大学国際医療センター(埼玉県)


Other administrative information

Date of disclosure of the study information

2009 Year 10 Month 30 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


Results


Results date posted


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

Preinitiation

Date of protocol fixation

2009 Year 10 Month 14 Day

Date of IRB


Anticipated trial start date

2009 Year 11 Month 01 Day

Last follow-up date

2011 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 10 Month 29 Day

Last modified on

2009 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003284


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name