UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046004 |
|---|---|
| Receipt number | R000052511 |
| Scientific Title | Angiotensin receptor-neprilysin inhibitor in patients with acute myocardial infarction and heart failure |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/11/07 15:09:37 |
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Basic information
Public title
Angiotensin receptor-neprilysin inhibitor in patients with acute myocardial infarction and heart failure
Acronym
Angiotensin receptor-neprilysin inhibitor in patients with acute myocardial infarction and heart failure
Scientific Title
Angiotensin receptor-neprilysin inhibitor in patients with acute myocardial infarction and heart failure
Scientific Title:Acronym
Acute MI and HF registry in Chiba
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of angiotensin receptor neprilysin inhibitor (ARNI) in patients with acute myocardial infarction (MI) and heart failure (HF)
Basic objectives2
Others
Basic objectives -Others
Trajectories of HF status after acute MI (changes in NT-proBNP)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) The safety of ARNI assessed with blood pressure, renal function, and potassium; 2) The change in NT-proBNP
Key secondary outcomes
Management in real-world practice, trajectory of natriuretic peptide, changes in echocardiographic parameters, and clinical events in patients with acute MI and HF
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
1) Patients with acute MI undergoing primary percutaneous coronary intervention (PCI) within 48 hours of onset
2) NT-proBNP >400 pg/ml
Key exclusion criteria
1) Maintenance hemodialysis
2) eGFR <30 ml/min/1.73 m2
3) Failed PCI (TIMI flow grade 0 or 1)
4) In-hospital death
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Saito |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
043-222-7171
saitoyuichi1984@gmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Saito |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
saitoyuichi1984@gmail.com
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine
Address
1-8-1, Inohana, Chuo-ku, Chiba
Tel
043-226-2501
inohana-rinri@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, prospective, observational study
Management information
Registered date
| 2021 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052511
