UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018636 |
|---|---|
| Receipt number | R000021573 |
| Scientific Title | Optical Coherence Tomography assessment for Coronary Artery Lesions with Calcification Registry |
| Date of disclosure of the study information | 2015/08/11 |
| Last modified on | 2019/08/14 11:59:58 |
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Basic information
Public title
Optical Coherence Tomography assessment for Coronary Artery Lesions with Calcification Registry
Acronym
Optical Coherence Tomography assessment for Coronary Artery Lesions with Calcification Registry (OCT-CALC Registry)
Scientific Title
Optical Coherence Tomography assessment for Coronary Artery Lesions with Calcification Registry
Scientific Title:Acronym
Optical Coherence Tomography assessment for Coronary Artery Lesions with Calcification Registry (OCT-CALC Registry)
Region
| Japan | Asia(except Japan) |
Condition
Condition
Coronary artery disease requiring percutaneous coronary intervention (PCI) for coronary artery lesions with severe calcification
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify the effect of percutaneous coronary intervention (PCI) for coronary artery lesions with calcification and the factors associated with clinical outcomes by sequential optical coherence tomography imaging during PCI.
Basic objectives2
Others
Basic objectives -Others
Presence of calcium crack after balloon dilatation and final stent area as assessed by OCT.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of calcium crack after balloon dilatation and final stent area as assessed by OCT.
Key secondary outcomes
Parameters analyzed by OCT
(1) Before PCI (in patients capable of undergoing OCT)
Calcification arc, calcification thickness, minimal lumen area
(2) After Rotational atherectomy (only in patients underwent Rotational atherectomy)
Calcification arc, calcification thickness, minimal lumen area
(3) After balloon dilatation
Presence of calcium crfack, presence of coronary artery dissection
(4) After stent implantation
Stent area, stent asymmetry index (minimum diameter/maximum diameter), presence of incomplete stent apposition, area of incomplete stent apposition
Outcome at 1 year
(1) Mortality
(2) Non-fatal myocardial infarctions
(3) Stent thrombosis
(4) Binary restenosis
(5) Target lesion revascularization
(6) Target vessel revascularization
(7) Composite endpoint including (1), (2), and (6) above
Exploratory parameter
An exploratory study of the correlation of platelet aggregation activity and CYP2C19 gene polymorphism with event occurrence
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patient with coronary artery disease requiring PCI
(2) Patient with moderate to severe calcification as detected by angiography
(3) Patient who will undergo balloon dilatation followed by stent implantation.
(4) Patients with lesion(s) observed by OCT both after balloon dilatation and after stent implantation
(5) Patient who has personally given written informed consent
Key exclusion criteria
(1) Culprit lesion(s) for ST elevation acute myocardial infarction
(2) Patient with cardiogenic shock
(3) Patient with acute decompensated heart failure
(4) Graft lesion or in-stent restenotic lesion
(5) Patient who has no indication for stent implantation
(6) Patient with chronic kidney disease who is not receiving dialysis therapy (serum Cr > 2 mg/dL)
(7) Lesion at the orifice of the left main trunk or the orifice of the right coronary artery
(8) Female patient who is pregnant or plans to become pregnant
(9) Patient who is deemed otherwise unsuitable by the investigator
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hibi |
Organization
YOKOHAMA CITY UNIVERSITY MEDICAL CENTER
Division name
Cardiovascular Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan
TEL
+81-45-261-5656
oct-calc@sa-tt.co.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Maejima |
Organization
YOKOHAMA CITY UNIVERSITY MEDICAL CENTER
Division name
Cardiovascular Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan
TEL
+81-45-261-5656
Homepage URL
oct-calc@sa-tt.co.jp
Sponsor or person
Institute
YOKOHAMA CITY UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuura(Advanced Medical Research Center)/Yokohama City University Hospital
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
045-370-7627
u_syomu@yokohama-cu.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
横浜市立大学附属市民総合医療センター（神奈川県）、横浜市立大学附属病院（神奈川県）、国際医療福祉大学熱海病院（静岡県）、神奈川県立循環器呼吸器病センター（神奈川県）、国立病院機構相模原病院（神奈川県）、済生会横浜市南部病院（神奈川県）、長津田厚生総合病院（神奈川県）、横須賀市立市民病院（神奈川県）、昭和大学藤が丘病院（神奈川県）、東海大学医学部付属病院（神奈川県）、東海大学医学部付属大磯病院（神奈川県）、東京医科歯科大学医学部附属病院（東京都）、岩槻南病院（東京都）、江戸川病院（東京都）、東京都保健医療公社豊島病院（東京都）、聖隷横浜病院（神奈川県）、東京都立多摩総合医療センター（東京都）、横浜栄共済病院（神奈川県）、榊原記念病院（東京都）、
昭和大学江東豊洲病院（東京都）、Jeju National University Hospital（大韓民国）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
This study is a cohort study.
The recruitment of subjects is all patients in line with eligibility criteria for selection in implementation medical institution consultation patients.
A measurement item to cast into analysis is findings by optical coherence tomography.
Management information
Registered date
| 2015 | Year | 08 | Month | 11 | Day |
Last modified on
| 2019 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021573
