UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study to establish simultaneous acquisition of 99m-Tc and 123-I-BMIPP tracers using SPECT with CZT detectors
Title of the study (Brief title)	A pilot study to establish simultaneous acquisition of 99m-Tc and 123-I-BMIPP tracers using SPECT with CZT detectors
Region	Japan

Condition
Condition	Ischemic heart disease(Acute coronary syndrome, Chronic coronary artery disease)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to Dual-tracer imaging of 123 I-BMIPP and 99mTc-TF labeled radiotracers for patients having a coronary artery disease using semiconductor SPECT equipped with the semiconductor digital CZT detector and collect the data to contribute to the optimization of the imaging protocol including time and resolution.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Shortening of the examination time and reduction of the quantity of radiation exposure.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	radiation exposure according to SPECT-CT
Interventions/Control_2	radiation exposure according to SPECT-CT
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	Diagnosis of Ischemic heart disease 20 years old or older Consenting to participate in the study
Key exclusion criteria	Unbearable to 15-minutes rest Potential pregnancy Previous enrollment within 28 days
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshihiro Yamada
Organization	International Medical Center, Saitama Medical University
Division name	Department of Cardiology
Address	1397-1 Yamane, Hidaka, Saitama 350-1298,Japan.
TEL	042-984-4111
Email	yyama@saitama-med.ac.jp

Public contact
Name of contact person	Yoshihiro Yamada
Organization	International Medical Center, Saitama Medical University
Division name	Department of Cardiology
Address	1397-1 Yamane, Hidaka, Saitama 350-1298,Japan.
TEL	042-984-4111
Homepage URL
Email	yyama@saitama-med.ac.jp

Sponsor
Institute	International Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	International Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 30 Day
Anticipated trial start date	2017 Year 11 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033972