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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031937
Receipt No. 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

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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
Email 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
Email kyohei@yamaji.info

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036476

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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