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18F-sodium fluoride positron emission tomography and near-infrared spectroscopy intravascular ultrasound for evaluation of coronary artery plaques in stenosis with deferred revascularization based on fractional flow reserve

18F-sodium fluoride positron emission tomography and near-infrared spectroscopy intravascular ultrasound for evaluation of coronary artery plaques in stenosis with deferred revascularization based on fractional flow reserve - 18F-NaF PET and NIRS-IVUS for evaluation of coronary plaques

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050751
Enrollment
15
Registered
2023-04-02
Start date
2023-04-02
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

Acute coronary syndrome

Interventions

After NIRS-IVUS for coronary arteries with FFR &gt
0.80, NaF-PET/CT of coronary plaque is performed within 1 month. For PET/CT, approximately 200 MBq of 18F-NaF is administered intravenously, and low-dose CT and PET images are taken 60 minutes later o

Sponsors

Aizawa Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients >=18 years of age. 2. Patients with ACS undergoing PCI within 4 weeks before study enrollment. 3. Patients with deferred coronary lesions by FFR (i.e. FFR>0.80) with a moderate stenosis (visual estimation of diameter stenosis >=50%, <90% by coronary angiography) in non-culprit coronary artery, assessed using NIRS-IVUS additionally.

Exclusion criteria

Exclusion criteria: 1. Target vessels* previously treated by PCI. 2. Target vessels* with significant coronary calcification or tortuosity deemed to preclude NIRS-IVUS evaluation. 3. Target vessels* with reference lumen diameter <=2mm. 4. History of CABG. 5. Unstable clinical status (hemodynamic or electrical instability). 6. Patients unwilling or unable to provide informed consent. 7. Life expectancy is less than 1 year at study enrollment. 8. Patients considered unsuitable for the study at the discretion of the operator. *Target vessel is defined as a non-culprit coronary artery with deferred coronary lesions by FFR (i.e. FFR>0.80) with a moderate stenosis (visual estimation of diameter stenosis >=50%, <90% by coronary angiography).

Design outcomes

Primary

MeasureTime frame
To compare 18F-sodium fluoride uptake of coronary artery on PET with NIRS-IVUS findings (e.g. maxLCBI(4mm)).

Countries

Japan

Contacts

Public ContactKeisuke Senda

Aizawa Hospital Department of Cardiology

k_senda@shinshu-u.ac.jp0263-33-8600

Outcome results

None listed

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