UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031937 |
|---|---|
| Receipt number | R000036476 |
| Scientific Title | PREDICTing long-term clinical outcomes by Optical coherence tomography assessment of plaque characteristics in the non-Revascularized coronary artery |
| Date of disclosure of the study information | 2018/03/28 |
| Last modified on | 2020/03/31 09:08:22 |
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Basic information
Public title
PREDICTing long-term clinical outcomes by Optical coherence tomography assessment of plaque characteristics in the non-Revascularized coronary artery
Acronym
PREDICTOR
Scientific Title
PREDICTing long-term clinical outcomes by Optical coherence tomography assessment of plaque characteristics in the non-Revascularized coronary artery
Scientific Title:Acronym
PREDICTOR
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective: To determine the predictive ability of plaque characteristics assessed by optical coherence tomography (OCT) in the non-target vessel with luminal irregularity (study imaging vessel) on luminal narrowing during 12 months. Plaque characteristics will be assessed, as potential predictors, manually by experienced assessors using validated software (QCU-CMS, LKEB, Leiden University, Leiden, Netherlands) and automatically using deep learning methods.
Secondary objective: To assess clinical impact of baseline and/or 12-month changes of OCT features on clinical cardiovascular adverse events during the long-term follow-up.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lumen area in the non-significant stenosis (%DS 30%-90%) assessed by OCT from baseline to 12-month follow-up.
Matching will be done using anatomical landmarks such as side branches and ostium of the coronary arteries.
Following OCT parameters will be assessed in paired frames between baseline and follow-up.
- Luminal area
- Fibrous cap thickness
- Lipid arc, lipid length
- Calcification arc, calcification length)
Key secondary outcomes
Secondary clinical endpoints
Any death, cardiac death, non-fatal myocardial infarction, and any ischemia-driven coronary artery revascularization.
Secondary safety endpoints
Amount of contrast used, cumulative radiation dose, intervention time, and any OCT procedure related adverse events.
Secondary CT endpoints
Changes in lumen volume in the non-culprit vessels assessed by computed tomography from baseline to 36-month follow-up.
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 who is 20 years of age or older at informed consent
2. Patients who submit signed consent by themselves or their legally acceptable representative
3. Elective or ad hoc PCI in patients with stable angina, acute coronary syndrome, or silent myocardial ischemia for target lesions in the native coronary artery. Target lesions fulfill at least one of the following criteria: 1) visually estimated %diameter stenosis >=90%, 2) fractional flow reserve <0.80, instantaneous wave-free ratio <0.89 or 3) presence of myocardial ischemia assessed by non-invasive test such as scintigraphy, stress echocardiography, and stress electrocardiography.
4. Patients who had at least one non-target coronary artery in which 1) no previously treated lesions and 2) non-severe stenosis (30% < visually estimated %DS < 90%) in the non-target vessel or >5mm apart from the culprit lesions. Except for contraindication, physicians are encouraged to confirm the stenosis is not significant by fractional flow reserve test (i.e. FFR>=0.80), instantanoues wave-free ratio (i.e. iFR>=0.89) or non-invasive test.
Key exclusion criteria
1. Subject with left main lesion.
2. Subject with a history of coronary artery bypass grafting.
3. Known renal insufficiency (estimated serum creatinine clearance <30ml/min or maintenance hemodialysis).
4. Severe angulation (>90 degrees) or excessive tortuosity (>two 45 degrees angles) not suitable for OCT assessments.
5. Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
6. Life expectancy less than 1 year.
7. Known allergy against protocol-required medications including aspirin, prasugrel, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated).
8. Cardiogenic shock or decompensate heart failure requiring intubation, vasopressors, and hemodynamic support (IABP and/or PCPS).
9. History of bleeding diathesis or known coagulopathy.
10. Planned surgery within the next 12 months
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Yamaji |
Organization
Kokura Memorial Hospital
Division name
Division of Cardiology
Zip code
802-8555
Address
Kokurakita Asano 3-2-1, Kitakyushu
TEL
+81-93-511-2000
kyohei@yamaji.info
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Yamaji |
Organization
Kokura Memorial Hospital
Division name
Division of Cardiology
Zip code
802-8555
Address
Kokurakita Asano 3-2-1, Kitakyushu
TEL
+81-93-511-2000
Homepage URL
kyohei@yamaji.info
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Abbott Vascular Japan Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kokura Memorial Hospital
Address
Asano 3-2-1, Kokurakita, Kitakyushu, Japan
Tel
+81-93-511-2000
rinsyo@kokurakinen.or.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
| 2018 | Year | 03 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Unpublished
Management information
Registered date
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036476
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