UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038983 |
|---|---|
| Receipt number | R000044455 |
| Scientific Title | Clinical Impact of Calcified Nodule in Patients with Heavily Calcified Lesions Requiring Rotational Atherectomy |
| Date of disclosure of the study information | 2019/12/25 |
| Last modified on | 2023/07/04 18:46:46 |
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Basic information
Public title
Clinical Impact of Calcified Nodule in Patients with Heavily Calcified Lesions Requiring Rotational Atherectomy
Acronym
Clinical Impact of Calcified Nodule in Patients with Heavily Calcified Lesions Requiring Rotational Atherectomy
Scientific Title
Clinical Impact of Calcified Nodule in Patients with Heavily Calcified Lesions Requiring Rotational Atherectomy
Scientific Title:Acronym
Clinical Impact of Calcified Nodule in Patients with Heavily Calcified Lesions Requiring Rotational Atherectomy
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We sought to assess the incidence and clinical impact of calcified nodule in patients with heavily calcified lesions requiring rotational atherectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the cumulative 5-year incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death,clinically driven target lesion revascularization, stent thrombosis. We sought to compare 5-year MACE between calcified nodule (CN) and non-CN groups.
Key secondary outcomes
(1) The prevalence of calcified nodule in lesions with heavily calcified lesions requiring rotational atherectomy.
(2) Assessment of IVUS findings when in-stent restenosis occurred after stent implantation in lesions with calcified nodule.
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) Angiographic or IVUS findings showed heavily calcified lesions requiring rotational atherectomy between Jan 2011 and February 2014
(2) Second-generation drug-eluting stent was implanted
(3) PCI was performed with IVUS guidance
Key exclusion criteria
(1) Cardiac arrest or cardiogenic shock at the index PCI
(2) Stent implantation except for second-generation drug-eluting stent
(3) A case that IVUS data was unanalyzable
Target sample size
264
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
8028555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu
TEL
0935112000
kuramitsu@circulation.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
8030835
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu
TEL
0935112000
Homepage URL
kuramitsu@circulation.jp
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokura Memorial Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kokura Memorial Hospital
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu
Tel
0935112000
kuramitsu@circulation.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
| 2019 | Year | 12 | Month | 25 | 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
264
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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective, observational study at a single center
Management information
Registered date
| 2019 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044455
