UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044517 |
|---|---|
| Receipt number | R000050435 |
| Scientific Title | The relation of endothelial dysfunction with cardiovascular events after acute coronary syndrome. A retrospective observational study of a single center |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2021/07/24 22:49:04 |
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Basic information
Public title
The relation of endothelial dysfunction with cardiovascular events after acute coronary syndrome.
Acronym
The relation of endothelial dysfunction with cardiovascular events after acute coronary syndrome.
Scientific Title
The relation of endothelial dysfunction with cardiovascular events after acute coronary syndrome. A retrospective observational study of a single center
Scientific Title:Acronym
The relation of endothelial dysfunction with cardiovascular events after acute coronary syndrome. A retrospective observational study of a single center
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association of endothelial dysfunction and bleeding events, cardiovascular events, and specific causes of death in patients with acute coronary syndrome
Basic objectives2
Others
Basic objectives -Others
Prognostic value
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
major bleeding
Key secondary outcomes
a composite outcome of cardiovascular death, non fatal myocardial infarction, or non fatal stroke.
all cause death, cardiovascular death, and non cardiovascular death.
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 were admitted with a diagnosis of acute coronary syndrome and underwent endothelial function assessment with reactive hyperemia peripheral arterial tonometry using the EndoPAT2000 system.
Patients who underwent coronary angiography and / or computed tomography coronary angiography and were diagnosed coronary artery diseases included atherosclerotic coronary artery stenosis, coronary artery embolism, spontaneous coronary artery dissection, or vasospastic angina.
Key exclusion criteria
Patients who were lost to follow up.
Patients whose endothelial function assessment were error.
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Matsuzawa |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
6-1 Kishibe Shimmachi, Suita, Osaka, Japan
TEL
045-261-5656
matsu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yoshii |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
6-1 Kishibe Shimmachi, Suita, Osaka, Japan
TEL
045-261-5656
Homepage URL
yoshii.tomohiro@ncvc.go.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama City University Medical Center
Address
4-57, Urafune-cho, Minami-ku, Yokohama, Kanagawa, Japan
Tel
045-261-5656
yoshii.tomohiro@ncvc.go.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 | 06 | Month | 20 | 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
688
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study of a single center. We included patients who were admitted to Yokohama City University Medical Center between June 2010 and November 2014 with a diagnosis of acute coronary syndrome and underwent endothelial function assessment.
Management information
Registered date
| 2021 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050435
