UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024812
Receipt No. R000028557
Scientific Title The sensitivity and prognostic values of the Wells and revised Geneva scores in the diagnosis of pulmonary embolism in the Japanese population:a retrospective study
Date of disclosure of the study information 2016/11/12
Last modified on 2018/08/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The sensitivity and prognostic values of the Wells and revised Geneva scores in the diagnosis of pulmonary embolism in the Japanese population:a retrospective study
Acronym The sensitivity and prognostic values of the Wells and revised Geneva scores in the diagnosis of pulmonary embolism in the Japanese population:a retrospective study
Scientific Title The sensitivity and prognostic values of the Wells and revised Geneva scores in the diagnosis of pulmonary embolism in the Japanese population:a retrospective study
Scientific Title:Acronym The sensitivity and prognostic values of the Wells and revised Geneva scores in the diagnosis of pulmonary embolism in the Japanese population:a retrospective study
Region
Japan

Condition
Condition Pulmonary embolism
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the sensitivity of Wells score (WS) and revised Geneva score (RGS) for the diagnosis of PE in the Japanese population.
Basic objectives2 Others
Basic objectives -Others To assess their prognostic values in the Japanese population with PE.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivities of WS and RGS
Key secondary outcomes

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients 16 years or older who were diagnosed with PE during an outpatient visit to the clinic at the Akashi Medical Center between December 2008 and August 2014.
PE was defined according to standardized criteria, using computed tomographic pulmonary angiography (CTPA), ventilation/perfusion pulmonary scans, angiography, or combinations of any of these modalities of investigation.
Key exclusion criteria Patients with a contraindication to CTPA (e.g. allergy to iodinated contrast agents, pregnancy), terminal illness with an expected survival of less than 3 months, and/or ongoing anticoagulant therapy at time of presentation.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Ishimaru
Organization Akashi Medical Center
Division name General Internal Medicine
Zip code
Address 743-33, Ohkubo-cho Yagi, Akashi, Hyogo 674-0063, Japan
TEL 078-936-1101
Email maru-tkb@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Ishimaru
Organization Akashi Medical Center
Division name General Internal Medicine
Zip code
Address 743-33, Ohkubo-cho Yagi, Akashi, Hyogo 674-0063, Japan
TEL 078-936-1101
Homepage URL
Email maru-tkb@umin.ac.jp

Sponsor
Institute General Internal Medicine, Akashi Medical Center
Institute
Department

Funding Source
Organization Akashi Medical Center
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.respiratoryinvestigation.com/article/S2212-5345(18)30113-8/fulltext
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 Completed
Date of protocol fixation
2016 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The outcome measures were the 2-Level Wells score (WS), the simplified Revised Geneva score, comorbidities, D-dimer assay, pulmonary infarction, and right ventricular dysfunction.

Management information
Registered date
2016 Year 11 Month 12 Day
Last modified on
2018 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028557

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.