UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036431 |
|---|---|
| Receipt number | 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 23:25:18 |
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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
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
yhiguchi-ja@umin.net
Sponsor or person
Institute
Osaka Police Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041498
