UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040824 |
|---|---|
| Receipt number | 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 | 2023/12/21 12:26:05 |
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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
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
h-ota@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 29 | 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
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045490
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
