UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045357 |
|---|---|
| Receipt number | R000050602 |
| Scientific Title | Comparison of Vascular Healing Response after Stent Implantation between Non-ST-Elevation Myocardial Infarction and ST-Elevation Myocardial Infarction: A Follow-up Optical Coherence Tomography Study |
| Date of disclosure of the study information | 2021/09/04 |
| Last modified on | 2022/03/05 12:54:35 |
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Basic information
Public title
Comparison of Vascular Healing Response after Stent Implantation between Non-ST-Elevation Myocardial Infarction and ST-Elevation Myocardial Infarction: A Follow-up Optical Coherence Tomography Study
Acronym
Stent Healing Response of Acute Myocardial Infarction
Scientific Title
Comparison of Vascular Healing Response after Stent Implantation between Non-ST-Elevation Myocardial Infarction and ST-Elevation Myocardial Infarction: A Follow-up Optical Coherence Tomography Study
Scientific Title:Acronym
Stent Healing Response of Acute Myocardial Infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarcion
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been revealed that patients with non-ST-elevation myocardial infarction (NSTEMI) have worse long-term prognosis than those with ST-elevation MI (STEMI). Degree of neointimal stent struts coverage is associated with the risk of stent thrombosis. This poor prognosis in patients with NSTEMI may be attributable to arterial healing response after stent deployment at the culprit lesion.We evaluated the difference of healing response after drug-eluting stents implantation between patients with NSTEMI and STEMI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the rate of the uncovered struts in patient with NSTEMI and STEMI at the one-year follow-up.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From May 2015 to Nov 2020, patients who underwent a one-year follow-up OFDI examination at Hyogo College of Medicine (Hyogo, Japan) will be reviewed.
Key exclusion criteria
OFDI pullbacks impaired imaging quality were not analyzable
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Ishihara |
Organization
Hyogo College of Medicine
Division name
Department of cardiovascular and renal medicine
Zip code
6638501
Address
1-1 Mukogawa Nishinomiya Hyogo, Japan
TEL
0798456553
ma-ishihara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Tanaka |
Organization
Hyogo College of Medicine
Division name
Department of cardiovascular and renal medicine
Zip code
6638501
Address
1-1 Mukogawa Nishinomiya Hyogo, Japan
TEL
0798456553
Homepage URL
ta-tanaka@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1 Mukogawa Nishinomiya Hyogo, Japan
Tel
0798456553
ta-tanaka@hyo-med.ac.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
| 2021 | Year | 09 | Month | 04 | 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
54
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
| 2020 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
m
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2022 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050602
