UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024577
Receipt No. 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 2017/04/27

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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
Middle name
Last name Takeshi Kimura
Organization Kyoto University Graduate School of Medicine
Division name Dept. of Cardiovascular Medicine
Zip code
Address 54 Kawaharacho, Shogo-in, Sakyo-ku, Kyoto
TEL 075-751-4254
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikiko Ohno
Organization Kyoto University Graduate School of Medicine
Division name Dept. of Cardiovascular Medicine
Zip code
Address 54 Kawaharacho, Shogo-in, Sakyo-ku, Kyoto
TEL 075-751-3187
Homepage URL
Email moono@kuhp.kyoto-u.ac.jp

Sponsor
Institute Dept. of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Institute
Department

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
Address
Tel
Email

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
2017 Year 04 Month 27 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028283

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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