UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018636
Receipt No. 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

* 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 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
Email 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
Email oct-calc@sa-tt.co.jp

Sponsor
Institute YOKOHAMA CITY UNIVERSITY
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.