UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052480 |
|---|---|
| Receipt number | R000059895 |
| Scientific Title | Prognostic Significance of Angiography-derived Index of Microcirculatory Index Assessment After Rotational Atherectomy in Patients with Severely Calcified Lesions |
| Date of disclosure of the study information | 2023/10/12 |
| Last modified on | 2023/10/12 21:55:27 |
* 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
Prognostic Significance of Angiography-derived Index of Microcirculatory Index Assessment After Rotational Atherectomy in Patients with Severely Calcified Lesions
Acronym
Prognostic Significance of Angiography-derived Index of Microcirculatory Index Assessment After Rotational Atherectomy in Patients with Severely Calcified Lesions
Scientific Title
Prognostic Significance of Angiography-derived Index of Microcirculatory Index Assessment After Rotational Atherectomy in Patients with Severely Calcified Lesions
Scientific Title:Acronym
Prognostic Significance of Angiography-derived Index of Microcirculatory Index Assessment After Rotational Atherectomy in Patients with Severely Calcified Lesions
Region
| Japan |
Condition
Condition
chronic coronary syndrome with severely calcified lesions
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate prognostic value of angiography-derived index of microcirculatory resistance(IMR) for predicting major adverse cardiovascular event(MACE) in patients who underwent percutaneous coronary intervention(PCI) with rotational atherectomy(RA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
major adverse cardiovascular event defined as cardiovascular death, non-fatal myocardial infarction, target vessel revascularization within 2 years following PCI with RA.
Key secondary 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive chronic coronary syndrome patients who underwent PCI with RA for severe calcified lesions at our institution.
Key exclusion criteria
1. patients with poor angiogram quality for calculating angiography-derived IMR.
2. restenosis lesion treated with a debulking device in the prior procedure.
3. first-generation drug eluting stent implantation.
4. coronary ostial lesion.
5. coronary artery graft lesion.
6. severe procedural complication such as persistent no flow, coronary perforation due to an RA burr, and requiring emergent surgical conversion.
7. hemodynamic instability at procedure.
8. patients who are deemed to ineligible for participation in this study by investigator.
Target sample size
150
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
078-382-5111
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sakamoto |
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
078-382-5111
Homepage URL
y.sakamoto1990@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 10 | Month | 12 | 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 | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
single-center, retrospective, observational study
Management information
Registered date
| 2023 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059895
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
