UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050115 |
|---|---|
| Receipt number | R000057087 |
| Scientific Title | The sensitivity of the PERC criteria in the diagnosis of pulmonary embolism in the Japanese population:a retrospective study |
| Date of disclosure of the study information | 2023/01/23 |
| Last modified on | 2023/12/09 10:46:52 |
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Basic information
Public title
The sensitivity of the PERC criteria in the diagnosis of pulmonary embolism in the Japanese population:a retrospective study
Acronym
The sensitivity of the PERC criteria in the diagnosis of pulmonary embolism in the Japanese population
Scientific Title
The sensitivity of the PERC criteria in the diagnosis of pulmonary embolism in the Japanese population:a retrospective study
Scientific Title:Acronym
The sensitivity of the PERC criteria in the diagnosis of pulmonary embolism in the Japanese population
Region
| Japan |
Condition
Condition
Pulmonary embolism
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the sensitivity of PERC criteria for the diagnosis of PE in the Japanese population.
Basic objectives2
Others
Basic objectives -Others
To assess the associated factors with the sensitivity of PERC criteria
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivities of the PERC criteria
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 December 2021.
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
Those diagnosed without standardized criteria.
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Yojiro |
| Middle name | |
| Last name | Cho |
Organization
Akashi Medical Center
Division name
General Internal Medicine
Zip code
6740063
Address
743-33, Ohkubo-cho Yagi, Akashi, Hyogo 674-0063, Japan
TEL
078-936-1101
chou.youjirou@aijinkai-group.com
Public contact
Name of contact person
| 1st name | Yojiro |
| Middle name | |
| Last name | Cho |
Organization
Akashi Medical Center
Division name
General Internal Medicine
Zip code
6740063
Address
743-33, Ohkubo-cho Yagi, Akashi, Hyogo 674-0063, Japan
TEL
078-936-1101
Homepage URL
chou.youjirou@aijinkai-group.com
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
Akashi Medical Center
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
Tel
0789361101
yokoyama.naoki@aijinkai-group.com
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
| 2023 | Year | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Demographic data, the diagnosis based on the PERC criteria and comorbidity were obtained from patient's charts.
Management information
Registered date
| 2023 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057087
