UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029397 |
|---|---|
| Receipt number | 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 | 2020/04/05 09:28:40 |
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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 | 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
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
kei.yunoki@gmail.com
Sponsor or person
Institute
Tsuyama Chuo Hospital
Department of Cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033595
