UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062096 |
|---|---|
| Receipt number | R000071050 |
| Scientific Title | European Association of Cardiovascular Imaging Inflammatory Cardiovascular Diseases Study |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/29 20:33:07 |
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Basic information
Public title
International prospective observational study of cardiovascular imaging in inflammatory cardiovascular diseases
Acronym
INFLAME study
Scientific Title
European Association of Cardiovascular Imaging Inflammatory Cardiovascular Diseases Study
Scientific Title:Acronym
EACVI-INFLAME study
Region
| Japan | Asia(except Japan) | North America |
| South America | Europe | Africa |
Condition
Condition
inflammatory cardiovascular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inflammatory cardiovascular diseases (ICARDs) encompass a broad spectrum of conditions, including myocarditis, pericarditis, vasculitis, and cardiovascular involvement associated with connective tissue diseases. However, evidence regarding the diagnostic and prognostic value of multimodality cardiovascular imaging remains limited. This international prospective observational study aims to evaluate the diagnostic and prognostic utility of multimodality cardiovascular imaging, including echocardiography, computed tomography, cardiac magnetic resonance imaging, and nuclear imaging, using real-world clinical data, and to provide evidence for the development of standardized diagnostic algorithms and optimal management strategies for ICARDs.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the diagnostic and prognostic value of multimodality cardiovascular imaging
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients with inflammatory cardiovascular diseases (ICARDs) undergoing cardiac magnetic resonance imaging or nuclear imaging in whom cardiovascular involvement is confirmed.
Key secondary outcomes
Baseline clinical characteristics, biological markers, and cardiovascular imaging findings.
Composite clinical outcome at 1 year (cardiovascular death, sustained ventricular arrhythmia, hospitalization for heart failure, new-onset atrial fibrillation, myocardial infarction, recurrence of ICARD, and stroke).
Individual outcomes including all-cause mortality, cardiovascular mortality, hospitalization for heart failure, recurrence of ICARD, hospitalization for acute ICARD, and ICARD remission.
Diagnostic performance of multimodality cardiovascular imaging according to the type of ICARD.
Long-term clinical outcomes up to 78 months, when available.
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
Patients fulfilling all of the following criteria will be eligible.
1. Age >=18 years.
2. Patients undergoing cardiac magnetic resonance imaging (CMR) or nuclear imaging for one of the following suspected or confirmed inflammatory cardiovascular diseases (ICARDs):
- Myocarditis (acute or chronic, regardless of etiology)
- Myocardial infarction with non-obstructive coronary arteries (MINOCA)
- Takotsubo syndrome
- Pericarditis (acute or chronic, regardless of etiology)
- Connective tissue diseases with cardiovascular involvement
- Systemic sclerosis
- Systemic lupus erythematosus
- Antiphospholipid syndrome
- Idiopathic inflammatory myopathies
- Rheumatoid arthritis or spondyloarthritis
- Vasculitis with cardiovascular involvement (including ANCA-associated vasculitis, Behcet disease, and Takayasu arteritis)
- Inflammatory diseases with cardiovascular involvement (including sarcoidosis and Still's disease)
Key exclusion criteria
Patients with a history of heart transplantation
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Kagiyama |
Organization
Juntendo University
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
kgnb_27_hot@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Kagiyama |
Organization
Juntendo University
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
kgnb_27_hot@yahoo.co.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
hongo-rinri@juntendo.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
| 2026 | Year | 07 | Month | 01 | 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
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2026 | Year | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071050
