UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044206
Receipt number R000050468
Scientific Title Multicenter prospective observational study stratifying phenotype of idiopathic cardiomyopathy patients with 99mTc-MIBI myocardial scintigraphy
Date of disclosure of the study information 2021/05/17
Last modified on 2023/05/15 10:15:48

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Multicenter prospective observational study stratifying phenotype of idiopathic cardiomyopathy patients with 99mTc-MIBI myocardial scintigraphy

Acronym

PERFUSION study

Scientific Title

Multicenter prospective observational study stratifying phenotype of idiopathic cardiomyopathy patients with 99mTc-MIBI myocardial scintigraphy

Scientific Title:Acronym

Multicenter prospective observational study with 99mTc-MIBI scintigraphy

Region

Japan


Condition

Condition

Idiopathic cardiomyopathy

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the ability to predict the progression of pathological conditions by indices that reflect the viable myocardium and myocardial mitochondrial function calculated by 99mTc-MIBI myocardial scintigraphy in multicenter prospective observational study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Predictability of LVRR after 1 year based on indices obtained from 99mTc-MIBI scintigraphy

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients without coronary artery disease (LVEF<40% in echocardiography) who consent to participation and have a scheduled 99mTc-MIBI scintigraphy

2.Patients who have a scheduled optimal therapy for heart failure and myocardial dysfunction

Key exclusion criteria

1.Patients with systemic disease with poor prognosis (within 1 year)
2.No follow-up
3.Patients without standard treatment
4.Patients judged to be inappropriate by investigator

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Yasushi
Middle name
Last name Sakata

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, 565-0871 Japan

TEL

06-6879-3631

Email

yasushisk@cardiology.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Tomohito
Middle name
Last name Ohtani

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, 565-0871 Japan

TEL

06-6879-3631

Homepage URL


Email

ohtani@cardiology.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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

Osaka University Clinical Research Review Committee

Address

Yamadaoka 2-15, Suita City, Osaka

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-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

大阪大学医学部附属病院(大阪府)
京都大学医学部附属病院(京都府)
関西医科大学(大阪府)
大阪急性期・総合医療センター(大阪府)
福岡大学病院 (福岡県)
聖マリアンナ医科大学病院 (神奈川県)
香川大学医学部 (香川県)
兵庫医科大学 (兵庫県)


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 17 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

114

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

No longer recruiting

Date of protocol fixation

2021 Year 04 Month 22 Day

Date of IRB

2021 Year 05 Month 11 Day

Anticipated trial start date

2021 Year 06 Month 23 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a prospective observational study.
Data for analysis is as follows:
*Indices of 99m-Tc-MIBI scintigraphy
*Cardiac events/ left ventricular reverse remodeling
*Echocardiographic data
*Patients characteristics, including laboratory data


Management information

Registered date

2021 Year 05 Month 13 Day

Last modified on

2023 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050468


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name