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 | 2024/05/05 22:40:04 |
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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
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
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
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
102
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
| 2024 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048215
