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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040824
Receipt No. R000045490
Scientific Title Clinical Utility of Low Radiation Dose Coronary CT Angiography with Iterative Reconstruction: Multi-center randomized control trial
Date of disclosure of the study information 2020/06/30
Last modified on 2020/06/18

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Basic information
Public title Clinical Utility of Low Radiation Dose Coronary CT Angiography with Iterative Reconstruction: Multi-center randomized control trial
Acronym LIBERATE trial
Scientific Title Clinical Utility of Low Radiation Dose Coronary CT Angiography with Iterative Reconstruction: Multi-center randomized control trial
Scientific Title:Acronym LIBERATE trial
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate non-inferiority of iterative-reconstruction-based coronary CT angiography for the short-term clinical impacts as compared with conventional coronary CT angiography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Ratio of patients with non-significant coronary artery stenosis determined by catheter coronary angiography performed during 90-days follow-up periods after CT examination.
Key secondary outcomes 1. Rate of patients who undergo noninvasive coronary tests other than cCTA within 90 days from cCTA.
2. Radiation exposure for a coronary test:
(1) DLP, effective radiation dose for cCTA
(2) The estimated cumulative effective radiation dose for cCTA, stress SPECT, stress PET-CT, ICA and PCI at 90 days follow-up
3. The image quality of CCTA:
(1) Rate and causes of unevaluable cCTA
(2) objective image quality (noise, SNR, and CNR)
(3) subjective image quality using a 4-grade scale.
4. Rate of patients who do not undergo revascularization after ICA within 90 days from cCTA.
5. Major Adverse Coronary Event rates at 90 days, defined as the composite rate of all-cause death, acute coronary syndrome and unplanned hospitalization leading to urgent revascularization.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Iterative-reconstruction-based coronary CT angiography will be acquired once following clinical indication of coronary CTA.
Interventions/Control_2 Conventional coronary CT angiography will be acquired once following clinical indication of coronary CTA.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) patients who agreed to participate in the study with written informed consent
2) patients with stable chest symptom
Key exclusion criteria 1) known coronary artery disease
2) history of coronary stenting or bypass surgery
3) heart failure with NYHA III or IV at the registration, or history of chronic heart failure with hospitalisation within 12 month before the registration
4) non-ischemic dilated cardiomyopathy or hypertrophic cardiomyopathy
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Ota
Organization Tohoku University Hospital
Division name Department of Diagnostic Radiology
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7312
Email h-ota@rad.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Ota
Organization Tohoku University Hospital
Division name Department of Diagnostic Radiology
Zip code 980-0824
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7312
Homepage URL
Email h-ota@rad.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University Graduate School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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
2020 Year 06 Month 30 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
2020 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 25 Day
Last follow-up date
2023 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 18 Day
Last modified on
2020 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045490

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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