UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022996
Receipt number R000026506
Scientific Title Optimal Medical Therapy Estimated by FDG PET/CT in Myocardial Sarcoidosis
Date of disclosure of the study information 2016/07/04
Last modified on 2023/07/09 12:01:54

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Basic information

Public title

Optimal Medical Therapy Estimated by FDG PET/CT in Myocardial Sarcoidosis

Acronym

Optimal Medical Therapy in Myocardial Sarcoidosis

Scientific Title

Optimal Medical Therapy Estimated by FDG PET/CT in Myocardial Sarcoidosis

Scientific Title:Acronym

Optimal Medical Therapy in Myocardial Sarcoidosis

Region

Japan


Condition

Condition

Myocardial sarcoidosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of FDG-PET/CT images in myocardial sarcoidosis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change of uptaking area estimated by 18F-FDG PET/CT

Key secondary outcomes

Frequency of sudden cardiac death, lethal arrhythmia and heart failure.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

mediacl therapy with methotrexate

Interventions/Control_2

medical therapy with steroid

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Myocardial sarcoidosis

Key exclusion criteria

The patients with
myelosuppression, chronic liver dysfunction, chronic kidney disease and infection.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Toyoaki
Middle name
Last name Murohara

Organization

Nagoya University Graduate School of Medicine

Division name

Cardiology

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-741-2111

Email

murohara@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Toyoaki
Middle name
Last name Murohara

Organization

Nagoya University Graduate School of Medicine

Division name

Cardiology

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-741-2111

Homepage URL


Email

ryota.m0726@med.nagoya-u.ac.jp


Sponsor or person

Institute

The Department of Cardiology, Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

Nagoya University Graduate School of Medicine

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

Tel

052-741-2111

Email

ryota.m0726@med.nagoya-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

名古屋大学病院


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 04 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

Completed

Date of protocol fixation

2016 Year 07 Month 03 Day

Date of IRB

2016 Year 10 Month 08 Day

Anticipated trial start date

2016 Year 10 Month 08 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 07 Month 03 Day

Last modified on

2023 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026506


Research Plan
Registered date File name
2017/02/13 別記様式第2号の4 研究計画書 sarcoidosis 9-5.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name