UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007606
Receipt No. 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

* 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 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
Institute Kansai Medical University
Institute
Department

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
URL(English) https://upload.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


Contact us.