UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043443 |
|---|---|
| Receipt number | R000049018 |
| Scientific Title | The prevalence and characteristics of chronic cardiac injury associated with COVID-19 |
| Date of disclosure of the study information | 2021/02/26 |
| Last modified on | 2021/02/25 23:17:37 |
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Basic information
Public title
The prevalence and characteristics of chronic cardiac injury associated with COVID-19
Acronym
TRACE-COVID
Scientific Title
The prevalence and characteristics of chronic cardiac injury associated with COVID-19
Scientific Title:Acronym
TRACE-COVID
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the prevalence and characteristics of chronic cardiac injury associated with COVID-19.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of cardiac injury associated with COVID-19 defined in the presence of at least one of the followings:
1. Presence of fibrosis in left or right ventricular detected by enhanced CMR
2. LVEF <50% and/or RVEF <45% measured by CMR
3. Pericardial thickening or enhancement
Key secondary outcomes
1. Comparing the following parameters between study subjects and age, gender, and risk-factors matched control;
- Strain analysis using CMR for both LV and RV
- Presence of myocardial LGE in LV or RV
- Abnormal native T1 and extracellular volume fraction (ECV)
2. In patients with available echocardiography imaging, accordance in LV/RV function between CMR and echocardiography.
3. Association between finding of lung fibrosis (using categories of normal/GGO/consolidation/emphysema) in CT scan and cardiac findings evaluated by CMR.
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 who meet the criteria for enrollment and consent to participate in the "Survey on the Sequelae of COVID-19 (for patients with moderate or severe disease)," the main study led by the Japanese Respiratory Society, and who meet either of the following (1), (2), or (3).
(1) High-sensitivity troponin positivity confirmed at least once during hospitalization or at the 3-month discharge follow-up
(2) A high-sensitivity troponin level recorded during hospitalization or up to 3 months after discharge that is confirmed to have increased by 50% or more from the time of hospitalization (or 150% or more of the sensitive concentration if the level at the time of hospitalization was less than the sensitive concentration)
(3) BNP or NT-proBNP recorded during hospitalization or up to 3 months after discharge, with BNP>=100 pg/mL or NT-proBNP >=300 pg/mL
* Reference; Inclusion criteria for the primary research
Patients who meet the following criteria will be eligible.
(1) Patients with moderate or severe disease according to the COVID-19 Clinical Practice Guidelines
(2) Patients who have been hospitalized for COVID-19 and have already been discharged or are expected to be discharged by December 31, 2021.
(3) Patients who have given consent
Key exclusion criteria
(1) A history of coronary artery disease (myocardial infarction or angina pectoris) or heart failure has been noted prior to admission.
2) Patients who are not suitable for contrast-enhanced MRI (claustrophobia, after implantation of metal in the body with MRI contraindication, severe renal dysfunction [eGFR<30mL/min/1.73m2], history of serious adverse reaction to gadolinium contrast agent (anaphylactic reaction), pregnant women).
* Reference; Exclusion criteria for the primary research
Subjects will be excluded from this study if they meet any of the following criteria
(1) Patients under 20 years of age
(2) Cases judged ineligible by the attending physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Node |
Organization
The Japanese Circulation Society
Division name
The Japanese Circulation Society, Managing Director
Zip code
101-0047
Address
Uchikanda Chu-oh Building 6F, 1-18-13, Uchikanda, Chiyoda-ku, Tokyo, Japan
TEL
03-6775-9111
node@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Matsue |
Organization
Juntendo University Hospital
Division name
Cardiology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
y-matsue@juntendo.ac.jp
Sponsor or person
Institute
The Japanese Circulation Society
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Oko-cho, Kohasu, Nankoku, Kochi
Tel
088-866-5811
rinri21@kochi-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
横浜市立大学附属病院/Yokohama City University Hospital
神奈川県立循環器呼吸器病センター/Kanagawa Cardiovascular and Respiratory Center
聖マリアンナ医科大学/St. Marianna University School of Medicine
聖マリアンナ医科大学横浜市西部病院/St. Marianna University Yokohama Seibu Hospital
東海大学医学部付属病院/Tokai University Hospital
神戸市立医療センター中央市民病院/ Kobe City Medical Center General Hospital
藤田医科大学/Fujita Health University
慶応義塾大学/ Keio University Hospital
順天堂大学医学部附属順天堂医院/ Juntendo University Hospital
国立国際医療研究センター病院/National Center for Global Health and Medicine
東京都立墨東病院/Tokyo Metropolitan Bokutoh Hospital
聖路加国際病院/St. Luke’s International Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study to be initiated at collaborating sites nationwide after IRB approval at the principle site
Management information
Registered date
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2021 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049018
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