UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026724 |
|---|---|
| Receipt number | R000030678 |
| Scientific Title | Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2024/04/30 10:19:06 |
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Basic information
Public title
Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Acronym
Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Scientific Title
Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Scientific Title:Acronym
Study on the relationship between optical coherence tomography findings and clinical prognosis in patients after coronary artery stent implantation
Region
| Japan |
Condition
Condition
Among the patients who had implanted the coronary artery stent, patients who underwent follow up OCT
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim to clarify the risk factors on clinical prognosis in OCT findings of patients with stent implantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death, myocardial infarction, TLR,TVR
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stent implantation who underwent OCT follow-up during the period from January 1, 2007 to March 31, 2016.
Key exclusion criteria
Patients meeting one of the following conditions will be excluded:
1) renal dysfunction (<Cre 2.0mg/dL)
2) severe heart failure (NYHA/New York Heart Association stage III or severer)
3) malignancies or other diseases with poor prognosis
4) pregnant, lactating, and possibly pregnant women and those planning to become pregnant
5) Patients who have offered to stop using data for this research
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5111
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Kuroda |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5111
Homepage URL
k722black@yahoo.co.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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
Address
Tel
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 | 03 | Month | 27 | Day |
Related information
URL releasing protocol
https://eurointervention.pcronline.com/article/peri-strut-low-intensity-area-assessed-by-midterm-fol
Publication of results
Published
Result
URL related to results and publications
https://eurointervention.pcronline.com/article/peri-strut-low-intensity-area-assessed-by-midterm-fol
Number of participants that the trial has enrolled
264
Results
We enrolled 264 consecutive patients treated with an EES who underwent follow-up OCT six to 12 months . PLIA was identified in 102 patients; 162 patients did not exhibit PLIA. PLIA (PLIA+) was an independent risk factor for an increased incidence of TLR . In both the early (<1 year) and late (>1 year) phases, the incidence of TLR was significantly higher in the PLIA+ group. Current smoking and increased C-reactive protein level were independently associated with PLIA+ .
Results date posted
| 2024 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The Kobe University Hospital OCT registry is a single-centre registry of consecutive patients who underwent OCT of the coronary arteries between April 2011 and March 2015. During this period, OCT was performed because of 1) planned follow-up coronary angiography and OCT for routine stent follow-up or for other study protocols, regardless of symptoms, and 2) evidence of myocardial ischemia such as silent myocardial ischemia, stable angina, or acute coronary syndrome (ACS). Patients enrolled in the registry who met the following criteria were included: 1) treatment with everolimus-eluting stents (EES; XIENCE V, Abbott Vascular, CA, USA, or Promus Element, Boston Scientific, Natick, Massachusetts) and 2) follow-up OCT examination 6-12 months after stenting. Among these patients, we excluded those with 1) a stent implanted in the left main trunk or 2) insufficient quality of OCT images.
Participant flow
Clinical outcome data were obtained by reviewing outpatient records or telephone interview for death, myocardial infarction (MI; defined according to the World Health Organization definition using creatine kinase and creatine kinase-MB increases), target lesion revascularisation (TLR), and a composite of death, MI, and TLR (MACE). TLR was performed clinically. These data were obtained by personnel blinded to follow-up OCT findings.
Adverse events
nothing
Outcome measures
The primary endpoint of this study was TLR during the follow-up period. TLR required >1 year after PCI was defined as late-phase TLR . All deaths were considered cardiac-related unless an unequivocal noncardiac cause could be established.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perform qualitative and quantitative analysis of OCT findings on each stent. There is no limit on the duration of the OCT follow up. Evaluation of clinical prognosis is the longest 5 years from the day of OCT procedure.
Management information
Registered date
| 2017 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030678
