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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036431
Receipt No. R000041498
Scientific Title Involvement of microcirculatory disturbance and plaque composition in the progression of myocardial injury associated with percutaneous coronary intervention
Date of disclosure of the study information 2019/05/01
Last modified on 2019/04/06

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Basic information
Public title Involvement of microcirculatory disturbance and plaque composition in the progression of myocardial injury associated with percutaneous coronary intervention
Acronym RESISTANCE Study
Scientific Title Involvement of microcirculatory disturbance and plaque composition in the progression of myocardial injury associated with percutaneous coronary intervention
Scientific Title:Acronym RESISTANCE Study
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to explore the involvement of microcirculatory disturbance and plaque composition on occurence of periprocedural myocardial infarction
Basic objectives2 Others
Basic objectives -Others to explore the involvement of microcirculatory disturbance and plaque composition on occurence of periprocedural myocardial infarction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes extent of PMI evaluated with high-sense troponin T the next day
Key secondary outcomes microcirculatory disturbance immediately after PCI
plaque composition

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
90 years-old >
Gender Male and Female
Key inclusion criteria presence of typical stable effort angina or a positive for myocardial ischemia
indication for planned PCI of a single lesion of native coronary artery
prescription with aspirin and prasugrel
written inforomed consent
Key exclusion criteria left ventriclar EF<30%
acute coronary syndrome
history of CABG
any increase in CK-MB or troponin before procedure
renal dysfunction with Cr>2mg/dL
physician's decision of ineligibility for entry
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshiharu
Middle name
Last name Higuchi
Organization Osaka Police Hospital
Division name Division of Cardiology
Zip code 5430035
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka City
TEL 0667756051
Email yhiguchi-ja@umin.net

Public contact
Name of contact person
1st name Yoshiharu
Middle name
Last name Higuchi
Organization Osaka Police Hospital
Division name Division of Cardiology
Zip code 5430035
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka City
TEL 0667756051
Homepage URL
Email yhiguchi-ja@umin.net

Sponsor
Institute Osaka Police Hospital
Institute
Department

Funding Source
Organization Osaka Police Hospital
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 Ethical Committee, Osaka Police Hospital
Address 10-31 Kiayama-cho, Tennoji-ku, Osaka City
Tel 0667756051
Email soumu@oph.gr.jp

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
2019 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information As of Now, Preparing study protocol

Management information
Registered date
2019 Year 04 Month 06 Day
Last modified on
2019 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041498

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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