Clinical Utility of Low Radiation Dose Coronary CT Angiography with Iterative Reconstruction: Multi-center randomized control trial

Clinical Utility of Low Radiation Dose Coronary CT Angiography with Iterative Reconstruction: Multi-center randomized control trial - LIBERATE trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000040824

Enrollment

500

Registered

2020-06-30

Start date

2020-07-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Iterative-reconstruction-based coronary CT angiography will be acquired once following clinical indication of coronary CTA. Conventional coronary CT angiography will be acquired once following clinic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients who agreed to participate in the study with written informed consent 2) patients with stable chest symptom

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Ratio of patients with non-significant coronary artery stenosis determined by catheter coronary angiography performed during 90-days follow-up periods after CT examination.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactHideki Ota

Tohoku University Hospital Department of Diagnostic Radiology

h-ota@rad.med.tohoku.ac.jp022-717-7312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026