UMIN-CTR Clinical Trial

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 Kei Middle name Last name Yunoki
Organization	Tsuyama Chuo Hospital
Division name	Department of Cardiology
Zip code	708-0841
Address	1756, Kawasaki, Tsuyama-city, Okayama
TEL	0868218111
Email	kei.yunoki@gmail.com

Public contact
Name of contact person	1st name Kei Middle name Last name Yunoki
Organization	Tsuyama Chuo Hospital
Division name	Department of Cardiology
Zip code	708-0841
Address	1756, Kawasaki, Tsuyama-city, Okayama
TEL	0868218111
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	Department of Cardiology, Tsuyama Chuo Hospital
Address	1756, Kawasaki, Tsuyama-city, Okayama
Tel	0868-21-8111
Email	ando11@tch.or.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	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	2017 Year 09 Month 06 Day
Anticipated trial start date	2017 Year 09 Month 06 Day
Last follow-up date	2020 Year 12 Month 31 Day
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	2020 Year 04 Month 05 Day

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