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

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 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

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

Value
https://center6.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