UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043669 |
|---|---|
| Receipt number | 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 | 2022/09/19 09:16:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
t.tsujimura0110@gmail.com
Sponsor or person
Institute
Kansai Rosai Hospital Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049868
