UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042248
Receipt number 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 2022/10/29 10:25:24

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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: -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 had first symptom of 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 or person

Institute

Yokohama City University

Institute

Department

Personal name



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

No longer 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

2022 Year 10 Month 29 Day



Link to view the page

Value
https://center6.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