UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012848
Receipt number R000011810
Scientific Title Validation of nuclear myocardial perfusion imaging system using a multifocal collimator (IQ-SPECT)
Date of disclosure of the study information 2014/01/15
Last modified on 2014/01/14 17:09:17

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Basic information

Public title

Validation of nuclear myocardial perfusion imaging system using a multifocal collimator (IQ-SPECT)

Acronym

Validation of IQ-SPECT

Scientific Title

Validation of nuclear myocardial perfusion imaging system using a multifocal collimator (IQ-SPECT)

Scientific Title:Acronym

Validation of IQ-SPECT

Region

Japan


Condition

Condition

coronary artery disease, cardiomyopathy

Classification by specialty

Cardiology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Validation of images obtained with a multifocal collimator (IQ-SPECT) versus those acquired with a conventional collimator

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defect score, quantitative tracer uptake

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Patients undergo stress myocardial SPECT/CT imaging with IQ-SPECT and a conventional collimator.

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who are referred for stress myocardial SEPCT/CT and who can lie on their back for more than 15 minutes.

Key exclusion criteria

Patients in whom stress myocardial SPECT is contradindicated.
Patients who can not lie on their back for more than 15 minutes.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukiko Morita

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Cardiology

Zip code


Address

18-1, Sakuradai, Minami-ku, Sagamihara City, Kanagawa, Japan

TEL

042-742-8311

Email

y-morita@sagamihara-hosp.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukiko Morita

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Cardiology

Zip code


Address

18-1, Sakuradai, Minami-ku, Sagamihara City, Kanagawa, Japan

TEL

042-742-8311

Homepage URL


Email

y-morita@sagamihara-hosp.or.jp


Sponsor or person

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

国立病院機構相模原病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 15 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

Completed

Date of protocol fixation

2012 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 14 Day

Last modified on

2014 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011810


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name