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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026878
Receipt No. R000030668
Scientific Title Association between Inframmatory cytokines and plaque morphology in Acute coronary syndrome
Date of disclosure of the study information 2017/04/06
Last modified on 2017/04/05

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Basic information
Public title Association between Inframmatory cytokines and plaque morphology in Acute coronary syndrome
Acronym Plaque morphology and cytokines in ACS
Scientific Title Association between Inframmatory cytokines and plaque morphology in Acute coronary syndrome
Scientific Title:Acronym Plaque morphology and cytokines in ACS
Region
Japan

Condition
Condition Acute coronary syndrme
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Inflammation is involved in the onset of acute coronary syndrome. Major mechanisms are plaque rupture and plaque erosion. To assess the plaque morphology and local inflammatory biomarkers.
Basic objectives2 Others
Basic objectives -Others Plaque morphology is assessed by optical coherence tomography.
Coronary blood is collected with aspiration catheter.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Plasma matrix matalloproteinase 9 andmyeloperoxidase in coronary circulation.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Collection of 5ml coronary blood with aspiration catheter before and after stent implantation.Collection of 5ml systemic blood.
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 Acute coronary syndrome within 6hrs from the onset
Key exclusion criteria Hemodynamic shock
Renal insufficiency (eGFR<35ml/min/1.73m2)
Active inflammatory disease
Tortuous vessel
Referrence diameter more than 4 mm
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Akasaka
Organization Wakayama Medical University
Division name Cardiovascular Medicine
Zip code
Address Kimiidera 811-1, Wakayama
TEL 073-441-0621
Email t-nsgc@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nishiguchi Tsuyoshi
Organization Wakayama Medical University
Division name Cardiovascular Medicine
Zip code
Address Kimiidera 811-1, Wakayama
TEL 073-441-0621
Homepage URL
Email t-nsgc@wakayama-med.ac.jp

Sponsor
Institute Cardiovascular Medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization Cardiovascular Medicine, Wakayama Medical University
Organization
Division
Category of Funding Organization Other
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
2017 Year 04 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://atvb.ahajournals.org/content/early/2016/09/29/ATVBAHA.116.308099.short
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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 04 Month 01 Day
Date analysis concluded
2016 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 05 Day
Last modified on
2017 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030668

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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