UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046910 |
|---|---|
| Receipt number | R000053523 |
| Scientific Title | Imaging Collagen Content in Human Coronary Atherosclerosis and Assessing its Role in Plaque Progression and Destabilization: A Clinical OCT-polarimetry Study |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/02/14 18:48:24 |
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Basic information
Public title
Imaging Collagen Content in Human Coronary Atherosclerosis and Assessing its Role in Plaque Progression and Destabilization: A Clinical OCT-polarimetry Study
Acronym
Intravascular OCT-polarimetry Registry
Scientific Title
Imaging Collagen Content in Human Coronary Atherosclerosis and Assessing its Role in Plaque Progression and Destabilization: A Clinical OCT-polarimetry Study
Scientific Title:Acronym
Intravascular OCT-polarimetry Registry
Region
| Japan |
Condition
Condition
Patients with coronary artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the role of collagen properties of coronary plaques in the progression and destabilization of coronary artery disease
Basic objectives2
Others
Basic objectives -Others
Exploring the clinical significance of polarization characteristics of plaque tissue in ACS culprit lesions
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The polarization characteristics (birefringence and degree of polarization resolution) of coronary artery lesions that develop ACS will be analyzed and compared with those of lesions in patients with CCS to identify determinants of ACS development (in patients who develop ACS due to in-stent restenosis or stent thrombosis, the polarization characteristics will be compared with those of in-stent neointima in patients with CCS).
Key secondary outcomes
1) Comparison of biomarkers (high-sensitivity CRP, high-sensitivity cardiac troponin I, CK-MB, IL-1beta, IL-6, MCP-1, MMP-2, MMP-9, MMP-13, adipokine) and polarization characteristics of coronary lesions
2) Evaluation of polarization characteristics of coronary lesions and acute response to stent therapy (stent expansion, stent-induced coronary dissection, slow-flow phenomenon, no-reflow phenomenon)
3) Coronary artery calcification angle, length, thickness, and polarization characteristics in relation to acute phase response to balloon dilation
4) Evaluation of chronic restenosis and predictors of chronic restenosis to treatment with drug-eluting balloons
5) Evaluation of stent restenosis and predictors by coronary CT or coronary angiography in the chronic phase
6) Progression of stenosis in non-responsible lesions by coronary CT or coronary angiography in chronic phase, evaluation of predictors
7) Comparison of peri-coronary adipose tissue attenuation index by coronary CT and polarization characteristics of coronary lesions
8) Comparison of coronary plaque volume and polarization characteristics by coronary CT
9) Comparison of lipid index and coronary plaque polarization characteristics by NIRS-IVUS
10) Comparison with coronary ischemia assessment (FFR, myocardial scintigraphy)
11) Combined events (all-cause mortality, cardiovascular death, myocardial infarction, unstable or stable angina requiring revascularization, stroke, transient ischemia, PCI / CABG, stent thrombosis and restenosis)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. scheduled to undergo coronary interventional treatment or OCT imaging at Osaka City University Hospital between April 2022 and March 2026
2. chronic coronary syndrome or acute coronary syndrome diagnosed by noninvasive coronary imaging or invasive coronary angiography
3. between 20 and 90 years of age at the time of initial consent.
Key exclusion criteria
1. patients diagnosed by physician as hemodynamically unstable at the time of enrollment
2. patients who cannot undergo coronary angiography or intracoronary imaging due to allergy to contrast media
3. patients with severe renal failure (eGFR less than 30ml/min/1.73mm2) who are not on maintenance dialysis
4. patients with a life expectancy of less than 1 year
5. pregnant women
Patients who are judged unsuitable for participation in this study by the principal investigator or sub-investigator for other reasons.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Otsuka |
Organization
Osaka City University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
545-8585
Address
1-4-3 Asahi-cho, Abeno-ku, Osaka, Japan
TEL
06-6645-3801
otsukakenichiro1@gmail.com
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Otsuka |
Organization
Osaka City University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
545-8585
Address
1-4-3 Asahi-cho, Abeno-ku, Osaka, Japan
TEL
06-6645-3801
Homepage URL
otsukakenichiro1@gmail.com
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS , the Japan Heart Foundation, the Takeda Science Foundation, Konica Minolta Science and Technology Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Graduate School of Medicine
Address
Cardioascular Medicine
Tel
06-6645-3801
otsukakenichiro1@gmail.com
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
大阪市立大学大学院医学研究科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | 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
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Various exploratory analyses will be conducted due to the study nature of the prospective registry
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053523
