UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032764
Receipt number R000037375
Scientific Title Does brachial artery flow-mediated dilation predict development of cardiac allograft vasculopathy in heart transplant recipients?
Date of disclosure of the study information 2018/07/01
Last modified on 2021/11/30 13:55:23

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Basic information

Public title

Does brachial artery flow-mediated dilation predict development of cardiac allograft vasculopathy in heart transplant recipients?

Acronym

TCAV-FMD observational study

Scientific Title

Does brachial artery flow-mediated dilation predict development of cardiac allograft vasculopathy in heart transplant recipients?

Scientific Title:Acronym

TCAV-FMD observational study

Region

Japan


Condition

Condition

Heart transplant recipients

Classification by specialty

Cardiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between brachial artery flow-mediated dilatation (FMD) findings and the development of cardiac allograft vasculopathy(CAV)

Basic objectives2

Others

Basic objectives -Others

To clarify the relationship between brachial artery flow-mediated dilatation (FMD) findings and the development of cardiac allograft vasculopathy(CAV)

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The relationship between the FMD value on baseline and the development of CAV from baseline to follow up

Key secondary outcomes

The relationship between the FMD value on baseline and the major adverse cardiac events from baseline to follow up


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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Heart transplant recipients who have a routine examination of post heart transplantation on admission among patient enrollment period

Key exclusion criteria

1) Patients who don't have coronary angiography and intravascular ultrasounds examination because of various causes, for example renal dysfunction

2) Patients who don't have coronary angiography and intravascular ultrasounds data to compare between baseline and follow up

3) Deemed unsuitable by the primary investigator for other reasons

Target sample size

123


Research contact person

Name of lead principal investigator

1st name Norihide
Middle name
Last name Fukushima

Organization

National cerebral and cardiovascular center in Japan

Division name

Department of transplant medicine

Zip code

564-8565

Address

6-1, Kishibe-shinmachi, Suita, Osaka, Japan

TEL

0661701069

Email

nori@ncvc.go.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Watanabe

Organization

National cerebral and cardiovascular center in Japan

Division name

Department of transplant medicine

Zip code

564-8565

Address

6-1, Kishibe-shinmachi, Suita, Osaka, Japan

TEL

0661701069

Homepage URL


Email

watanabe.takuya@ncvc.go.jp


Sponsor or person

Institute

Department of transplant medicine, National cerebral and cardiovascular center

Institute

Department

Personal name



Funding Source

Organization

Ministry of education, culture, sports, science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National cerebral and cardiovascular center

Address

6-1, Kishibe-shinmachi, Suita, Osaka, Japan

Tel

0661701069

Email

rec-office-ac@ncvc.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 07 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

Open public recruiting

Date of protocol fixation

2018 Year 06 Month 25 Day

Date of IRB

2018 Year 07 Month 05 Day

Anticipated trial start date

2018 Year 07 Month 05 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

ongoing


Management information

Registered date

2018 Year 05 Month 29 Day

Last modified on

2021 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037375


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name