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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037154
Receipt No. R000042333
Scientific Title The risk factors for predicting death or need for surgery in patients with acute type A intramural hematoma receiving medical therapy
Date of disclosure of the study information 2019/06/24
Last modified on 2019/06/24

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Basic information
Public title The risk factors for predicting death or need for surgery in patients with acute type A intramural hematoma receiving medical therapy
Acronym Risk score on admission predicts fatal events
Scientific Title The risk factors for predicting death or need for surgery in patients with acute type A intramural hematoma receiving medical therapy
Scientific Title:Acronym Risk score on admission predicts fatal events
Region
Japan

Condition
Condition Acute type A intramural hematoma
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to examine the incidences and risk factors of death or need for surgery for acute type A IMH in patients receiving medical treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Primary endpoint was a composite of cardiovascular death and operation within 1 year after onset.
Key secondary outcomes All couse death, cardiovascular death, and cardiovascular surgery during follow up

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria From 2011 to 2016, 208 patients with confirmed acute aortic syndrome were admitted to the Shizuoka City Shizuoka Hospital. Among them, 57 consecutive patients who were diagnosed with type A IMH and who received medical therapy were retrospectively analyzed. All patients underwent physical and laboratory examinations such as blood testing.
Key exclusion criteria *The patients who did not met the clinical diagnosis of acute type A IMH.
*Those who were initially treated by invasive treatment like emergent surgery.
*Those who were not treated (e.g. CPAOA) but were diagnosed as acute type A IMH with autopsy or AI.
Target sample size 57

Research contact person
Name of lead principal investigator
1st name SHIGETAKA
Middle name
Last name KAGEYAMA
Organization Shizuoka city Shizuoka Hospital
Division name department of cardiology
Zip code 4208630
Address 10-93, Ohtemachi, Aoi-ku, Shizuoka, Japan
TEL +81-54-253-3125
Email shigenewf@yahoo.co.jp

Public contact
Name of contact person
1st name SHIGETAKA
Middle name
Last name KAGEYAMA
Organization Shizuoka city Shizuoka hospital
Division name department of cardiology
Zip code 4208630
Address 10-93, Ohtemachi, Aoi-ku, Shizuoka, Japan
TEL +81-54-253-3125
Homepage URL
Email shigenewf@yahoo.co.jp

Sponsor
Institute Shizuoka city Shizuoka hospital
department of cardiology
Institute
Department

Funding Source
Organization none
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 Shizuoka City Shizuoka Hospital
Address 10-93, Ohtemachi, Aoi-ku, Shizuoka, Japan
Tel 054-253-3125
Email chiken2@shizuokahospital.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 静岡市立静岡病院(静岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 24 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 57
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
2018 Year 06 Month 12 Day
Date of IRB
2019 Year 04 Month 18 Day
Anticipated trial start date
2018 Year 06 Month 12 Day
Last follow-up date
2018 Year 09 Month 05 Day
Date of closure to data entry
2018 Year 09 Month 05 Day
Date trial data considered complete
2019 Year 04 Month 08 Day
Date analysis concluded
2019 Year 07 Month 01 Day

Other
Other related information From 2011 to 2016, 57 consecutive patients diagnosed with acute type A IMH who were receiving treatment at Shizuoka City Shizuoka Hospital were retrospectively included. The primary endpoint was a composite of cardiovascular death and operation within 1 year after onset. To evaluate sensitivity and specificity of the risk factors and risk score, we estimated the area under the receiver operating characteristic (ROC) curve.

Management information
Registered date
2019 Year 06 Month 24 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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