UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041725 |
|---|---|
| Receipt number | R000047618 |
| Scientific Title | The Usefulness of Cardiac CT in Heart Failure |
| Date of disclosure of the study information | 2020/09/08 |
| Last modified on | 2020/09/08 14:07:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Usefulness of Cardiac CT in Heart Failure
Acronym
The Usefulness of Cardiac CT in Heart Failure
Scientific Title
The Usefulness of Cardiac CT in Heart Failure
Scientific Title:Acronym
The Usefulness of Cardiac CT in Heart Failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the influence of various parameters (Coronary artery stenosis/plaque information, CT strain, LIE-CT, etc.) obtained from cardiac CT on prognosis in patients with heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All deaths, cardiac deaths, hospitalization for heart failure(5 years after cardiac CT)
Key secondary outcomes
Lethal arrhythmia, new atrial fibrillation, CRT/pacemaker placement(5 years after cardiac CT)
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 diagnosed with heart failure who undergo cardiac CT to screen for coronary artery disease
Key exclusion criteria
1.Patients with a history of hypersensitivity to iodine or iodinated contrast media
2.Patients with asthma and patients with uncontrolled hyperthyroidism
3.pregnant woman
4.When the research director or the research subinvestigator determines that it is not appropriate to participate in the research
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Tanabe |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
7910295
Address
Shitsukawa, Toon City, Ehime
TEL
089-960-5371
yuki.tanabe.0225@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Tanabe |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
7910295
Address
Shitsukawa, Toon City, Ehime
TEL
089-960-5371
Homepage URL
yuki.tanabe.0225@gmail.com
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Ehime University Hospital Clinical Research Support Center
Address
Shitsukawa, Toon City, Ehime
Tel
089-960-5914
cttc@m.ehime-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 08 | 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
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center prospective study
Management information
Registered date
| 2020 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047618
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
