UMIN-CTR Clinical Trial

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
Email	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
Email	yoshii.tomohiro@ncvc.go.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050435