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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029397
Receipt No. R000033595
Scientific Title Relationship of coronary culprit lesion morphology and thrombus grade in patients with acute coronary syndrome
Date of disclosure of the study information 2017/10/03
Last modified on 2017/10/03

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Basic information
Public title Relationship of coronary culprit lesion morphology and thrombus grade in patients with acute coronary syndrome
Acronym Coronary culprit lesion morphology and thrombus grade in ACS
Scientific Title Relationship of coronary culprit lesion morphology and thrombus grade in patients with acute coronary syndrome
Scientific Title:Acronym Coronary culprit lesion morphology and thrombus grade in ACS
Region
Japan

Condition
Condition acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship of coronary culprit lesion morphology and thrombus grade in patients with acute coronary syndrome
Basic objectives2 Others
Basic objectives -Others To investigate the relationship of coronary culprit lesion morphology and visible or pathological aspirated thrombus characteristics in patients with acute coronary syndrome
To investigate major adverse cardiovascular and cerebrovascular event rate during one year between ACS patients with plaque rupture and non-plaque rupture, high thrombus and low thrombus burden or red and no-red thrombus
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relationship of coronary culprit lesion morphology (plaque rupture and non-plaque rupture) and TIMI thrombus grade in patients with acute coronary syndrome
Key secondary outcomes Relationship of coronary culprit lesion morphology (plaque rupture and non-plaque rupture) and visible or pathological aspirated thrombus characteristics in patients with acute coronary syndrome
Major adverse cardiovascular and cerebrovascular event rate during one year between ACS patients with plaque rupture and non-plaque rupture, high thrombus and low thrombus burden or red and no-red thrombus

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 1. The group evaluated coronary culprit lesion morphology as plaque rupture by the imaging modalities
2. The group evaluated thrombus grade as high thrombus burden by coronary angiography
3. The group evaluated aspirated thrombus as visual or pathological red thrombus
Interventions/Control_2 1. The group evaluated coronary culprit lesion morphology as non-plaque rupture by the imaging modalities
2. The group evaluated thrombus grade as low thrombus burden by coronary angiography
3. The group evaluated aspirated thrombus as visual or pathological no or little red thrombus
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with de novo acute coronary syndrome (ACS) within 24 hours after symptom onset(unstable angina pectoris, non-ST elevation myocardial infarction and ST-elevation myocardial infarction)
2. ACS patients performed emergent coronary angiography and primary percutaneous coronary intervention
3. ACS patients evaluated coronary culprit lesion morphology by the imaging modalities
Key exclusion criteria 1. Patients with ACS exceeding 24 hours after symptom onset
2. ACS patients with variant angina, stent restenosis or bypass graft failure
3. ACS patients not evaluated or difficult to evaluate coronary culprit lesion morphology by the imaging modalities
4. Inadequate patients by phisician's discresion
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yunoki Kei
Organization Tsuyama Chuo Hospital
Division name Department of Cardiology
Zip code
Address 1756, Kawasaki, Tsuyama-city, Okayama
TEL 0868-21-8111
Email kei.yunoki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yunoki Kei
Organization Tsuyama Chuo Hospital
Division name Department of Cardiology
Zip code
Address 1756, Kawasaki, Tsuyama-city, Okayama
TEL 0868-21-8111
Homepage URL http://www.tch.or.jp/clinical_research.html
Email kei.yunoki@gmail.com

Sponsor
Institute Tsuyama Chuo Hospital
Department of Cardiology
Institute
Department

Funding Source
Organization Tsuyama Chuo Hospital
Department of Cardiology
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
2017 Year 10 Month 03 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
2017 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 06 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
2017 Year 10 Month 03 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033595

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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