UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044762 |
|---|---|
| Receipt number | R000051112 |
| Scientific Title | Delayed contrast-enhanced computed tomography for assessment of myocardial injury after coronavirus disease 2019 (COVID-19) infection |
| Date of disclosure of the study information | 2021/07/05 |
| Last modified on | 2023/04/26 12:02:35 |
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Basic information
Public title
Delayed contrast-enhanced computed tomography for assessment of myocardial injury after coronavirus disease 2019 (COVID-19) infection
Acronym
Delayed contrast-enhanced computed tomography for assessment of myocardial injury after coronavirus disease 2019 (COVID-19) infection
Scientific Title
Delayed contrast-enhanced computed tomography for assessment of myocardial injury after coronavirus disease 2019 (COVID-19) infection
Scientific Title:Acronym
Delayed contrast-enhanced computed tomography for assessment of myocardial injury after coronavirus disease 2019 (COVID-19) infection
Region
| Japan |
Condition
Condition
coronavirus disease 2019 (COVID-19) infection
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to evaluate the clinical utility of delayed contrast-enhanced computed tomography for the assessment of myocardial injury in patients after recovery from coronavirus disease 2019 (COVID-19) infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiovascular events (MACE: the composite of all-cause mortality, lethal ventricular arrhythmias [sustained ventricular tachycardia/ventricular fibrillation], myocardial infarction, and stroke), heart failure or unstable angina requiring hospitalization, and thromboembolic events after the delayed contrast-enhanced computed tomography examination.
Key secondary outcomes
The prespecified secondary outcomes of the study are as follows:
1. prevalence of coronary artery disease and myocardial injury assessed by contrast-enhanced computed tomography.
2. diagnostic value of delayed contrast-enhanced computed tomography for the assessment of myocardial injury in comparison with late gadolinium enhancement cardiovascular magnetic resonance
3. cross-sectional and longitudinal associations between myocardial injury, echocardiographic indices, and biomarkers.
4. incidence and predictors of all-cause death, MACE, MACE+.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients 18 years of age or older are eligible.
2. Patients after recovery from coronavirus disease 2019 (COVID-19) infection are eligible. Diagnosis of COVID-19 requires at least 1 positive polymerase chain reaction result for SARS-CoV-2 in the nasopharyngeal swab or sputum.
3. Patients who are scheduled for coronary computed tomography angiography are eligible.
4. Patients who provided informed consent are eligible.
Key exclusion criteria
1. Patients expected to live a year or less
2. Patients with insufficient image quality of delayed contrast-enhanced computed tomography
3. Patients who withdraw their consent
4. Patients who contact persons judge as ineligible for this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Aikawa |
Organization
Hokkaido Cardiovascular Hospital
Division name
Cardiology
Zip code
064-8622
Address
1-30, Minami-27, Nishi-13, Chuo-ku, Sapporo 064-8622, Japan
TEL
011-563-3911
tadao.aikawa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Aikawa |
Organization
Hokkaido Cardiovascular Hospital
Division name
Cardiology
Zip code
064-8622
Address
1-30, Minami-27, Nishi-13, Chuo-ku, Sapporo 064-8622, Japan
TEL
011-563-3911
Homepage URL
tadao.aikawa@juntendo.ac.jp
Sponsor or person
Institute
Hokkaido Cardiovascular Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuda Foundation for Medical Technology
Akiyama Life Science Foundation
The Uehara Memorial Foundation
The Cardiovascular Research Fund
Sakakibara Memorial Research Grant
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido Cardiovascular Hospital
Address
1-30, Minami-27, Nishi-13, Chuo-ku, Sapporo 064-8622, Japan
Tel
011-563-3911
hokujyunncrc1@gmail.com
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
北海道循環器病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 05 | 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 | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051112
