UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051172 |
|---|---|
| Receipt number | R000058360 |
| Scientific Title | A 5-year follow-up study after screening of ischemic heart disease in Japanese hemophiliacs living with HIV-1 |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/06/01 12:29:31 |
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Basic information
Public title
A 5-year follow-up study after screening of ischemic heart disease in Japanese hemophiliacs living with HIV-1
Acronym
Hem-IHD5y
Scientific Title
A 5-year follow-up study after screening of ischemic heart disease in Japanese hemophiliacs living with HIV-1
Scientific Title:Acronym
Hem-IHD5y
Region
| Japan |
Condition
Condition
HIV
Hemophilia
Ischemic heart disease
Classification by specialty
| Cardiology | Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of coronary artery stenosis by coronary CT in participants in the Hem-IHD study after 5 years
Basic objectives2
Others
Basic objectives -Others
Prospective observational study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Degree of coronary artery stenosis by coronary CT
Key secondary outcomes
Effects of drug interventions on coronary risk factors
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Coronary CT
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
1. Participants in the Hem-IHD study
2. Person who understands this research study and consents in the agreement form
Key exclusion criteria
1) Patients with a history of hypersensitivity to iodine or iodine contrast media
2) Patients with serious thyroid disease
3) Patients with bronchial asthma
4) Patient with history of heart disease such as ischemic heart disease or heart failure
5) Patients with severe hepatic impairment
6) Patients with severe renal dysfunction
7) Patients with macroglobulinemia
8) Patients with multiple myeloma
9) Patients with tetany
10) Patients with pheochromocytoma or suspected pheochromocytoma
11) Patients of childbearing potential
12) Those who are judged by the principal investigator to be inappropriate for inclusion in the study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Hiroi |
Organization
National Center for Global Health and Medicine, Center Hospital
Division name
Cardiology
Zip code
1628655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
yhiroi@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Hiroi |
Organization
National Center for Global Health and Medicine, Center Hospital
Division name
Cardiology
Zip code
1628655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
yhiroi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
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
Division of Medical Research Management, Management and Planning Bureau National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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 | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058360
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
