UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007606
Receipt number R000008980
Scientific Title Japanese Assessment of BMIPP and CTA for Diagnostic utility in Suspected Angina Patients
Date of disclosure of the study information 2012/03/31
Last modified on 2014/11/13 10:22:05

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Basic information

Public title

Japanese Assessment of BMIPP and CTA for Diagnostic utility in Suspected Angina Patients

Acronym

Japanese Assessment of BMIPP and CTA for Diagnostic utility in Suspected Angina Patients (J-ABCD Study)

Scientific Title

Japanese Assessment of BMIPP and CTA for Diagnostic utility in Suspected Angina Patients

Scientific Title:Acronym

Japanese Assessment of BMIPP and CTA for Diagnostic utility in Suspected Angina Patients (J-ABCD Study)

Region

Japan


Condition

Condition

Ischemic heart disease

Classification by specialty

Cardiology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate weather incidence of cardiovascular event in ischemic heart disease patients with BMIPP SPECT and CT angiography for stratification of cardiovascular events.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cardiac death, Sudden death

Key secondary outcomes

Non fatal myocardial infarction,
hospitalization for heart failure or unstable angina, stroke, aorta dissection, aorta rupture, pulmonary embolism, performed PCI or CABG


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)Suspected ischemic heart disease patients due to who has chest pain and/or exertional breathlessness

2)Patients(age above 20) who are obtained written informed consent

Key exclusion criteria

1)History of myocardial infarction
2)Acute coronary syndrome
3)History of hospitalization by heart failuer
4)History of coronary revascularization
5)CKD patient(eGFR<=50mL/min/1.73m2)
6)Uncontrollable arrhythmia or AF
7)Uncontrollable hypertension
8)Overt valve regurgitation and/or moderate to severe valvular disease on UCG
9)Coronary angiography or CT angiography within 2 months before registration
10)Drug hypersensitivity with BMIPP and Tetrofosmin
11)Unsuitable for registration by investigator

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuya Takehana

Organization

Kansai Medical University

Division name

Second Department of Medicine

Zip code


Address

10-15 Fimizono-cho, Moriguchi, Osaka

TEL

06-6992-1001

Email

takehana@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takehana Kazuya

Organization

Kansai Medical University

Division name

Second Department of Medicine

Zip code


Address

10-15 Fimizono-cho, Moriguchi, Osaka

TEL

06-6992-1001

Homepage URL


Email

takehana@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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


Address


Tel


Email



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

2012 Year 03 Month 31 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

Terminated

Date of protocol fixation

2012 Year 01 Month 17 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Kontos MC, Dilsizian V, Weiland F, et al; Iodofiltic acid I 123(BMIPP) Fatty Acid Imaging Improves Initial Diagnosis in Emergency Department Patients With Suspected Acute Coronary Syndromes.
The study aim to assess the improving of BMIPP imaging to detect ACS in emergency department with chest pain patients.
Result: addition of BMIPP data helpful for diagnosis of ACS in emergency department.


Management information

Registered date

2012 Year 03 Month 29 Day

Last modified on

2014 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008980


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name