UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053243 |
|---|---|
| Receipt number | R000060761 |
| Scientific Title | Quantification analysis of lung fluid status using chest computed tomography for determining the clinical characteristics in patients with heart failure |
| Date of disclosure of the study information | 2023/12/27 |
| Last modified on | 2023/12/27 16:50:40 |
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Basic information
Public title
Quantification analysis of lung fluid status using chest computed tomography for determining the clinical characteristics in patients with heart failure
Acronym
Quantification analysis of lung fluid status using chest computed tomography for determining the clinical characteristics in patients with heart failure
Scientific Title
Quantification analysis of lung fluid status using chest computed tomography for determining the clinical characteristics in patients with heart failure
Scientific Title:Acronym
Quantification analysis of lung fluid status using chest computed tomography for determining the clinical characteristics in patients with heart failure
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish dual-energy CT as a novel modality to quantitatively evaluate lower limb blood flow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
From this study, it is possible to evaluate the degree of heart failure and life expectancy by single analysis of mean Lung density obtained from CT imaging. As a result, medication changes and device adjustments can be made on an outpatient basis prior to hospitalization, reducing the need for hospitalization and preventing an increase in medical costs.
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
This study included patients with congestive heart failure underwent chest CT on admission
Key exclusion criteria
The patients who did not undergo CT, and missing data regarding the analysis of CT image were excluded
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Uzui |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
+81-776-61-8800
huzui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Uzui |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
+81-776-61-8800
Homepage URL
huzui@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
self funding
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
University of Fukui Medical research support center
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
Tel
+81-776-61-8529
chiken@ml.u-fukui.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
| 2023 | Year | 12 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of the relationship between the degree of pulmonary congestion using CT and the severity of heart failure in the early stage of hospitalization.
CT image analysis.
The degree of pulmonary congestion is assessed using lung analysis software from images obtained.
Data analysis
MLD will be calculated after CT imaging and the relationship between the value and the following data obtained from heart failure patients will be examined.
Clinical Background
NYHA Heart Failure Functional Classification, Sepsis-related Organ Failure Assessment (SOFA) score, Quality of Life score (Kansas City Cardiomyopathy Questionnaire (KCCQ))
Hematological data
BNP, high sensitive C-reactive protein (hs-CRP),
UCG: overall cardiac function: tei-index, left ventricular function: LVEF, global longitudinal strain; GLS
right ventricular function: right ventricular fractional area Right: FAC, tricuspid annular plane systolic excursion (TAPSE).
ECG: HR, axis ,rhythm, QRS complex time
Chest-XP
In the same way as above, examine the period listed in for the purpose.
Finally, to examine whether pulmonary congestion is a useful for predicting clinical outcome data in heart failure patients.
Management information
Registered date
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060761
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