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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043669
Receipt No. R000049868
Scientific Title Morphological Evaluation of Culprit Lesion in Patients with Acute Myocardial Infarction Using Coronary Angioscopy and Optical Coherence Tomography
Date of disclosure of the study information 2021/03/19
Last modified on 2021/03/19

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Basic information
Public title Morphological Evaluation of Culprit Lesion in Patients with Acute Myocardial Infarction Using Coronary Angioscopy and Optical Coherence Tomography
Acronym COLLABORATION Morphology Study
Scientific Title Morphological Evaluation of Culprit Lesion in Patients with Acute Myocardial Infarction Using Coronary Angioscopy and Optical Coherence Tomography
Scientific Title:Acronym COLLABORATION Morphology Study
Region
Japan

Condition
Condition Acute myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare intravascular images between high-resolution coronary angioscopy and optical coherence tomography.
Basic objectives2 Others
Basic objectives -Others Morphology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the findings between high-resolution coronary angioscopy (CAS) and optical coherence tomography (OCT) as follows:
1) CAS thrombus and OCT findings
2) Specific findings by CAS and OCT findings
3) Fibrous cap thickness by OCT and CAS findings
Key secondary outcomes To compare the detection power between CAS and OCT as follows:
1) Morphology of acute myocardial infarction
2) Presence of thrombus
3) Presence of lipid-rich plaque

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 To observe intravascular status using optical coherence tomography and high-resolution coronary angioscopy continuously immediately after obtaining TIMI 3 flow.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Twenty years of age or over at the time of informed consent
2) Singed informed consent after receiving the explanation about the study protocol
3) ST elevation myocardial infarction or non-ST elevation myocardial infarction
4) Arrival at the hospital within 12 hours from the onset of the symptom
5) Identifiable culprit lesion in a native coronary artery by coronary angiography
Key exclusion criteria 1) Pregnancy
2) In-stent restenosis
3) Cardiogenic shock
4) Active bleeding complication
5) Participation or scheduled to participate to the other clinical trial or interventional study
6) Life expectancy within 1 year
7) Severe dementia
8) Severe chronic insufficiency or hemodialysis
9) Inappropriate to the study judged by investigators
10) Lesion in left main trunk
11) Previous history of old myocardial infarction
12) Impossible to obtain TIMI 3 flow before OCT and CAS evaluation
13) Impossible to perform sufficient observation by OCT or CAS
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Ishihara
Organization Kansai Rosai Hospital
Division name Cardiovascular Center
Zip code 660-8511
Address Inabaso 3-1-69, Amagasaki, Hyogo, Japan
TEL 06-6416-1221
Email t.ishihara31@gmail.com

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Tsujimura
Organization Kansai Rosai Hospital
Division name Cardiovascular Center
Zip code 660-8511
Address Inabaso 3-1-69, Amagasaki, Hyogo, Japan
TEL 06-6416-1221
Homepage URL
Email t.tsujimura0110@gmail.com

Sponsor
Institute Kansai Rosai Hospital Cardiovascular Center
Institute
Department

Funding Source
Organization Japan Organization of Occupational Health and Safety
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 Kansai Rosai Hospital
Address Inabaso 3-1-69, Amagasaki, Hyogo, Japan
Tel 06-6416-1221
Email chiken@kansaih.johas.go.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 関西労災病院(兵庫県)、大阪労災病院(大阪府)、大阪急性期・総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 19 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 15 Day
Date of IRB
2021 Year 03 Month 15 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 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
2021 Year 03 Month 19 Day
Last modified on
2021 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049868

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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