UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053548 |
|---|---|
| Receipt number | R000061107 |
| Scientific Title | A single-center prospective observational study to investigate the actual situation of acute coronary syndrome and myocardial infarction with non-obstructive arteries. |
| Date of disclosure of the study information | 2024/02/06 |
| Last modified on | 2024/02/06 00:35:42 |
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Basic information
Public title
A single-center prospective observational study to investigate the actual situation of acute coronary syndrome and myocardial infarction with non-obstructive arteries.
Acronym
A single-center prospective observational study to investigate the actual situation of acute coronary syndrome and myocardial infarction with non-obstructive arteries.
Scientific Title
A single-center prospective observational study to investigate the actual situation of acute coronary syndrome and myocardial infarction with non-obstructive arteries.
Scientific Title:Acronym
A single-center prospective observational study to investigate the actual situation of acute coronary syndrome and myocardial infarction with non-obstructive arteries.
Region
| Japan |
Condition
Condition
acute coronary syndrome and myocardial infarction with non-obstructive arteries
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence and prognosis of acute coronary syndrome and myocardial infarction with non-obstructive arteries (MINOCA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diseases of patients who underwent emergency cardiac catheterization and/or percutaneous coronary intervention for acute coronary syndrome or MINOCA (acute coronary syndrome [STEMI, NSTEMI, UAP], MINOCA [plaque rupture/erosion, coronary spasm, coronary artery Dissection, acute aortic dissection, microangiopathy, coronary thrombosis [due to thrombotic predisposition], coronary embolism, sympathomimetic drugs [cocaine, methamphetamine], myocarditis, Takotsubo cardiomyopathy, other cardiomyopathy, cardiac trauma, excessive exercise, Tachyarrhythmia, drug-induced myocardial injury [chemotherapy], disruption of oxygen supply and demand balance [type-2 myocardial infarction], cerebral infarction, pulmonary thromboembolism, sepsis, acute respiratory distress syndrome, end-stage renal failure, cause unknown]) ratio of
Key secondary outcomes
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 who understood the contents of the written informed consent provided by the research director or co-investigator and signed the consent form in their own handwriting or by their representative.
Patients diagnosed with acute myocardial infarction and MINOCA who underwent emergency coronary angiography and/or percutaneous coronary intervention due to clinical necessity.
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Atushi |
| Middle name | |
| Last name | Tnaka |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
a-tanaka@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Jumpei |
| Middle name | |
| Last name | Takeda |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
Homepage URL
jtakeda@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Abbott Japan LLC
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama City
Tel
073-447-2300
wa-rinri@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2024 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061107
