UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037154 |
|---|---|
| Receipt number | 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 21:42:09 |
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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
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
shigenewf@yahoo.co.jp
Sponsor or person
Institute
Shizuoka city Shizuoka hospital
department of cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042333
| 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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