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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035307
Receipt No. R000040232
Scientific Title Establishment of diagnosis method of ischemic heart disease in patients with hemophilia and HIV
Date of disclosure of the study information 2018/12/21
Last modified on 2019/06/20

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Basic information
Public title Establishment of diagnosis method of ischemic heart disease in patients with hemophilia and HIV
Acronym Hem-IHD
Scientific Title Establishment of diagnosis method of ischemic heart disease in patients with hemophilia and HIV
Scientific Title:Acronym Hem-IHD
Region
Japan

Condition
Condition hemophilia with HIV
Classification by specialty
Cardiology Hematology and clinical oncology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the prevalence of ischemic heart disease in hemophilia with HIV by coronary CT
Basic objectives2 Others
Basic objectives -Others To clarify the correlation between patient information such as risk factor in hemophilia with HIV and ischemic heart disease
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of ischemic heart disease in hemophilia with HIV
Key secondary outcomes Correlation between risk factors and ischemic heart disease in hemophilia with HIV

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. Person who understands this research study and consents in the agreement form
2. Person who has been diagnosed as hemophilia
3. Person with HIV positive result
Key exclusion criteria 1. Person who has a history of hypersensitivity to iodine or iodine contrast medium
2. Person contraindicated or in principle contraindicated for the use of contrast agents such as severe renal dysfunction
3. Person who has a possibility of pregnancy
4. Those who have judged that the research director is inappropriate for inclusion in this research
Target sample size 50

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 162-8655
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL 03-3202-7181
Email 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 162-8655
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL 03-3202-7181
Homepage URL
Email yhiroi@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
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 National Center for Global Health and Medicine
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel 03-3202-7181
Email 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
2018 Year 12 Month 21 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
2018 Year 11 Month 26 Day
Date of IRB
2018 Year 11 Month 26 Day
Anticipated trial start date
2019 Year 01 Month 04 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 19 Day
Last modified on
2019 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040232

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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