UMIN-CTR Clinical Trial

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	37
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	No longer recruiting
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	2022 Year 09 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049868