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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042248
Receipt No. R000048215
Scientific Title Relationship between COVID-19 infection and new onset and prognosis of vasospastic angina; Multi-center, prospective, observational study
Date of disclosure of the study information 2020/11/11
Last modified on 2020/10/26

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Basic information
Public title The relationship between COVID-19 Infection and new onset and prognosis of vasospastic angina: Multi-center prospective study
Acronym The relationship between COVID-19 Infection and vasospastic angina
Scientific Title Relationship between COVID-19 infection and new onset and prognosis of vasospastic angina; Multi-center, prospective, observational study
Scientific Title:Acronym The relationship between COVID-19 Infection and vasospastic angina
Region
Japan

Condition
Condition COVID-19 infection and vasospastic angina
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate whether coronavirus infection is associated with the development of vasospastic angina and its prognosis.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigate the rereshionship between the presence and absence of antibody (IgG )of COVID-19 and the following endpoints.

Primary endpoints;
We will compare the prevalence of COVID-19 antibody in patients with vasospasitic angina that developed before and after the COVID-19 infection epidemic.

Key secondary outcomes Relationship between the presence or absence of new coronavirus antibody and 5 year cardiovascular events from registration.

All cause death
Cardiovascular death
Myocardial infarction
cerebral infarction
Coronary artery revascularization
Hospitalization for heart failure
Revascularization for peripheral arterial disease
Arrhythmia attacks requiring change of treatment
Deep vein thrombosis, pulmonary embolism

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 Before the COVID-19 epidemic: 2017/1 / 1-2020 / 1/31
During the COVID-19 epidemic: 2020/3 / 1-20 21/3/31

COVID-19 IgG antibody will be collected from patients undergoing outpatient treatment who were diagnosed with vasospastic angina during the above period.
Key exclusion criteria Nothing in particular
Target sample size 300

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 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa
TEL 045-261-5656
Email matsu@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Jin
Middle name
Last name Kirigaya
Organization Yokohama City University Medical Center
Division name Advanced Care and Emergency Center
Zip code 232-0024
Address 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa
TEL 045-261-5656
Homepage URL
Email kirigaya@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Division of Cardiology, Yokohama City University Medical Center
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 Advanced Medical Research Center, Yokohama City University
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel 045-787-2311
Email rinri@yokohama-cu.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
2020 Year 11 Month 11 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 Comparison of antibody prevalence before and after the epidemic of COVID-19 infection.

5 years of cardiovascular events (total death, cardiovascular death, myocardial infarction, stroke, coronary artery structure reconstruction, hospitalization for heart failure, revascularization for peripheral arterial disease, arrhythmia attack requiring outpatient or inpatient treatment, deep vein thrombosis Disease and pulmonary embolism).

In addition, a part of the blood test will be used as a preserved sample to investigate intestinal bacterial metabolites.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 06 Month 29 Day
Date of IRB
2020 Year 07 Month 10 Day
Anticipated trial start date
2020 Year 07 Month 10 Day
Last follow-up date
2030 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multi-center, prospective, observational study

Management information
Registered date
2020 Year 10 Month 27 Day
Last modified on
2020 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048215

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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