UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017903 |
|---|---|
| Receipt number | R000017193 |
| Scientific Title | Acute Chest Pain Registry |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2015/06/15 13:01:05 |
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Basic information
Public title
Acute Chest Pain Registry
Acronym
Acute Chest Pain Registry
Scientific Title
Acute Chest Pain Registry
Scientific Title:Acronym
Acute Chest Pain Registry
Region
| Japan |
Condition
Condition
Patients referred to the emergency department for acute chest pain
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To stratify the patient risk of acute chest pain with them measurement of d-dimer levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
final diagnosis of acute aortic dissection
Key secondary outcomes
the composite endpoint of acute coronary sundrome, aortic dissection, and pulmonary embolism
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
patients referred to the emergency department for acute chest pain
Key exclusion criteria
discharge patients before admission
death patients before admission
patients referred to other hospital
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyofuku Mamoru |
Organization
Wakayama Medical Center
Division name
Cardiology
Zip code
Address
4-20 Komatsubara street Wakayama City
TEL
073-422-4171
matoyofuku-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Toyofuku |
Organization
Wakayama Medical Center
Division name
Cardiology
Zip code
Address
4-20 Komatsubara street Wakayama City
TEL
073-422-4171
Homepage URL
matoyofuku-circ@umin.ac.jp
Sponsor or person
Institute
Japanese Red Cross Society Wakayama Medical Center
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
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
| 2015 | Year | 06 | Month | 15 | 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
Measurement of D-dimer was usefule rule out tool for the manegiment of patients presenting acute chest pain.
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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 15 | Day |
Other
Other related information
The D-dimer level was obviously increased in patients with acute aortic syndrome as compared with control patients (Median 4.9 micro-g/dl, IQR 2.0-17.4 vs. 0.6 0.3-1.4, p<0.001). With the cutoff point of 0.5 micro-g /ml, the specificity of acute aortic syndrome with 0.97 (95% confidence interval 0.92-0.99) and was similar to that of acute pulmonary embolism (0.97, 0.82-0.99). The age adjusted D-dimer cutoff point, defined as age x 0.01micro-g /ml in patients 50 years or older, successfully reduced 13 percent of false-positive cases while retaining a high sensitivity of 0.96(0.91-0.99).
Management information
Registered date
| 2015 | Year | 06 | Month | 15 | Day |
Last modified on
| 2015 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017193
