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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002886
Receipt No. R000003521
Scientific Title The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Date of disclosure of the study information 2009/12/13
Last modified on 2018/12/01

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Basic information
Public title The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Acronym The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Scientific Title The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Scientific Title:Acronym The Impact of Eicosapentaenoic Acid Pretreatment on Periprocedural Microcirculatory Damage in Patients Undergoing Percutaneous Coronary Intervention
Region
Japan

Condition
Condition Patients with stable angina pectoris who undergo percutaneous coronary intervention
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of eicosapentaenoic acid pretreatment on post-procedural microvascular damage by intracoronary pressure/temperature sensor-tipped guide wire.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in index of microcirculatory index
Key secondary outcomes 1)Absolute value of the CK-MB and high-sensitive troponin I measured at 8 and 24 hours after PCI
2)Absolute and percent changes of lipid profiles
3)Absolute and percent changes of high-sensitive CRP, VCAM-1, and MMP-9

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pravastatin treatment (1800mg daily) 4 weeks before elective PCI
Interventions/Control_2 no pretreatment
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Stable angina pectoris
2)Culprit lesion involving 75% or more of the stenosis
3)Patients with dyslipidemia: LDL-cho >=100mg/dL and patients who are judged by the investigator as needing cholesterol lowering therapy
4)Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation of the study
Key exclusion criteria 1)Target PCI lesion is left main coronary artery
2)Target PCI lesion is graft stenosis or in-stent restenosis
3)Patients on hemodialysis
4)Patients with acute coronary syndrome
5)Patients with contraindication of antiplatelet of anticoagulation drug
6)Patients with a history of hypersensitivity to any of the components of the product
7)Patients who are judged by the principal investigator to be ineligible for enrollment in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Masuyama
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL 0798-45-6553
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Fujii
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL 0798-45-6553
Homepage URL
Email

Sponsor
Institute Cardiovascular Division, Hyogo College of Medicine
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 13 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
2009 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 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
2009 Year 12 Month 13 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003521

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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