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
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
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
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
