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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014121
Receipt No. R000016437
Scientific Title Randamized evaluation of the effects of filter-based distal protection in anginal patients with hyperintense plaque detected by coronary MR imaging
Date of disclosure of the study information 2014/05/30
Last modified on 2018/12/03

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Basic information
Public title Randamized evaluation of the effects of filter-based distal protection in anginal patients with hyperintense plaque detected by coronary MR imaging
Acronym Randamized evaluation of the effects of filter-based distal protection in anginal patients with hyperintense plaque detected by coronary MR imaging
Scientific Title Randamized evaluation of the effects of filter-based distal protection in anginal patients with hyperintense plaque detected by coronary MR imaging
Scientific Title:Acronym Randamized evaluation of the effects of filter-based distal protection in anginal patients with hyperintense plaque detected by coronary MR imaging
Region
Japan

Condition
Condition angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of filter-based protection among the anginal patients with vulnerable plaque detected by MR imaging
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The elevation of cardiac enzymes after primary coronary intervention
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients without hyperintense plaque undergoing PCI with distal protection device
Interventions/Control_2 Patients with hyperintense plaque undergoing PCI with distal protection device
Interventions/Control_3 Patients with hyperintense plaque undergoing PCI without distal protection device
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with stable or unstable angina pectoris undergoing elective percutaneous coronary intervention
Key exclusion criteria (1) Patients with acute myocardial infarction
(2) Patients contraindicated to MRI
(3) Patients who do not wish to participate in this clinical test
(4) Patients judged as inappropriate by a treating physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Yoshiyama
Organization Osaka city university graduate school of medicine
Division name Department of cardiovascular medicine
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan.
TEL 06-6645-3801
Email yoshiyama@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichi Ehara
Organization Osaka city university graduate school of medicine
Division name Department of cardiovascular medicine
Zip code
Address achi, Abeno-ku, 1-4-3 Asahi-mOsaka 545-8585, Japan.
TEL 06-6645-3801
Homepage URL
Email ehara@med.osaka-cu.ac.jp

Sponsor
Institute Department of cardiovascular medicine, Osaka city university graduate school of medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of cardiovascular medicine, Osaka city university graduate school of medicine
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 大阪市立大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 30 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 Open public recruiting
Date of protocol fixation
2013 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 26 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 05 Month 30 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016437


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