UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024812 |
|---|---|
| Receipt number | 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 14:30:09 |
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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
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
maru-tkb@umin.ac.jp
Sponsor or person
Institute
General Internal Medicine, Akashi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028557
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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