UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024577 |
|---|---|
| Receipt number | R000028283 |
| Scientific Title | Prospective evaluation of Nardilysin for the early detection of patients with Acute Coronary Syndrome |
| Date of disclosure of the study information | 2016/10/27 |
| Last modified on | 2024/11/01 14:12:23 |
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Basic information
Public title
Prospective evaluation of Nardilysin for the early detection of patients with Acute Coronary Syndrome
Acronym
Nardi-ACS Study
Scientific Title
Prospective evaluation of Nardilysin for the early detection of patients with Acute Coronary Syndrome
Scientific Title:Acronym
Nardi-ACS Study
Region
| Japan |
Condition
Condition
ACS, Takotsubo syndrome, pulmonary embolism, Aortic dissection, others
Classification by specialty
| Cardiology | Laboratory medicine | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We demonstrate here that NRDC could be a biomarker for the early detection of ACS.
Basic objectives2
Others
Basic objectives -Others
We demonstrate that NRDC could be a biomarker for the early detection of ACS, even in UA patients with no significant elevation of biomarkers for myocardial necrosis such as cTn.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ACS, serum NRDc concentration, high sensitive troponin I
Key secondary outcomes
Acute aortic dissection, pulmonary embolism, Takotsubo syndrome, troponin T, MACE (30 days after onset)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with informed concent
Key exclusion criteria
patients without informed concent
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Dept. of Cardiovascular Medicine
Zip code
6068507
Address
54 Kawaharacho, Shogo-in, Sakyo-ku, Kyoto
TEL
075-751-4254
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Shiomi |
Organization
Kyoto University Graduate School of Medicine
Division name
Dept. of Cardiovascular Medicine
Zip code
6068507
Address
54 Kawaharacho, Shogo-in, Sakyo-ku, Kyoto
TEL
075-751-3187
Homepage URL
hishiomi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Dept. of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MECST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Abbott Japan
Sanyo chemical industries
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Shogoin Kawahara-cho 54, Sakyoku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院(京都府)、小倉記念病院(福岡県)、倉敷中央病院(岡山県)、済生会野江(大阪府)、大阪赤十字病院(大阪府)、三菱京都病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 10 | Month | 31 | Day |
Other
Other related information
we evaluate the serum concentration of NRDC, and analyze the AUC using ROC, compare the diagnostic accuracy with cTnI. MACE for 30 days after onset
Management information
Registered date
| 2016 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028283
