UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050297
Receipt number R000057191
Scientific Title Clinical outcome of patients with calcified nodule detected by Optical coherence tomography after percutaneous coronary intervention
Date of disclosure of the study information 2023/04/01
Last modified on 2023/08/12 16:52:42

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Basic information

Public title

Clinical outcome of patients with calcified nodule detected by Optical coherence tomography after percutaneous coronary intervention

Acronym

CANDO registry

Scientific Title

Clinical outcome of patients with calcified nodule detected by Optical coherence tomography after percutaneous coronary intervention

Scientific Title:Acronym

CANDO registry

Region

Japan


Condition

Condition

coronary calcified nodule

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

he purpose of this study was to prospectively investigate the frequency of major cardiovascular events after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) or drug-coated balloons (DCB) in patients with ischemic heart disease who had calcified nodules in the culprit lesion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Patient-oriented Composite Endpoint (PoCE) at 12 months after PCI: composite endpoint of all cause death, myocardial infarction and any revascularization
Target lesion failure (TLF) at 12 months after PCI: composite endpoint of cardiac death, target vessel-related MI and clinically driven target lesion revascularization (TLR)

Key secondary outcomes

At 12 months after PCI
1) The components of primary outcomes
2) Stent thrombosis
3) Stroke
4) Bleeding event
5) Time to occurrence of each of the primary outcomes

At 24 months after PCI
6) The composite endpoint of PoCE
7) The composite endpoint of TLF
8) The components of primary outcomes
9) Stent thrombosis
10) Stroke
11) Bleeding event
12) repeated TLR
13) Time to occurrence of each of the primary 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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with calcified nodules in the culprit lesion detected by OCT or OFDI
2) Patients treated with DES or DCB
3) Patients over 20 years old
4) Patients with their own consent

Key exclusion criteria

1) patients with life expectancy < 1 year
2) patients with shock status
3) patients with in-stent restenosis or stent thrombosis
4) patients with pregnancy
5) Patients deemed inappropriate for inclusion by the principal investigator or subinvestigator

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Hiromasa
Middle name
Last name Otake

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo

TEL

078-382-5846

Email

hotake@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Tetsuya
Middle name
Last name Yamamoto

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo

TEL

078-382-5846

Homepage URL


Email

m07100ty@jichi.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name

Tetsuya Yamamoto


Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Ethics Committee of Kobe University Hospital

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo

Tel

078-382-5846

Email

kansatsu@med.kobe-u.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

2023 Year 04 Month 01 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

Preinitiation

Date of protocol fixation

2023 Year 04 Month 01 Day

Date of IRB

2023 Year 03 Month 29 Day

Anticipated trial start date

2023 Year 04 Month 01 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2023 Year 02 Month 10 Day

Last modified on

2023 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057191


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name