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 | 2024/09/06 17:38:14 |
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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
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
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
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
Enrolling by invitation
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
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057191
