UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035307
Receipt number 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 2020/12/21 09:49:09

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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 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

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

国立国際医療研究センター(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 21 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.35772/ghm.2020.01080

Number of participants that the trial has enrolled

57

Results

The median age was 47 years (interquartile range: 44-52 years). Moderate to severe CAS was diagnosed in 14 patients by CCTA (24.6% of CCTA tested). Twelve patients agreed to undergo CAG and 7 patients were diagnosed as severe CAS by CAG (12.3% of CCTA received). PWV and CACS were useful and significant non-invasive markers of moderate to severe CAS (p = 0.016, p < 0.001, respectively).

Results date posted

2020 Year 12 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 12 Month 28 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2020 Year 12 Month 21 Day



Link to view the page

Value
https://center6.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