UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047978 |
|---|---|
| Receipt number | R000054697 |
| Scientific Title | Study of COVID-19-related thromboembolism and chronic sequelae and prognosis |
| Date of disclosure of the study information | 2022/06/07 |
| Last modified on | 2023/06/08 14:05:04 |
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Basic information
Public title
Study of COVID-19-related thromboembolism and chronic sequelae and prognosis
Acronym
Study of COVID-19-related thromboembolism and chronic sequelae and prognosis
Scientific Title
Study of COVID-19-related thromboembolism and chronic sequelae and prognosis
Scientific Title:Acronym
Study of COVID-19-related thromboembolism and chronic sequelae and prognosis
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency, duration of symptoms, and prognosis of true cardiovascular disease in the sequelae of COVID-19
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of cardiovascular impairment
Type and duration of sequelae
Prognosis
Key secondary outcomes
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
Patients aware of post-COVID-19 symptoms
Key exclusion criteria
Pregnant women, lactating women, and women who may be pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | NOBUHIRO |
| Middle name | |
| Last name | MURATA |
Organization
Nihon University Itabashi Hospital
Division name
Department of Cardiology
Zip code
173-8610
Address
Tokyo, Itabashi, Oyaguchi-kamimachi 30-1
TEL
03-3972-8111
murata.nobuhiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | NOBUHIRO |
| Middle name | |
| Last name | MURATA |
Organization
Nihon University Itabashi Hospital
Division name
Department of Cardiology
Zip code
173-8610
Address
Tokyo, Itabashi, Oyaguchi-kamimachi 30-1
TEL
03-3972-8111
Homepage URL
murata.nobuhiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Department of Cardiology
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
Center for Clinical Research, Nihon University Itabashi Hospital
Address
Tokyo, Itabashi, Oyaguchi-kamimachi 30-1
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.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
日本大学医学部板橋病院（東京）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 07 | 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
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An observational study of the frequency, duration of symptoms, and prognosis of true cardiovascular disorders such as chest pain, palpitations, and respiratory distress in patients with cardiovascular-related LongCOVID
Management information
Registered date
| 2022 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054697
