18F-Sodium Fluoride uptake for cardiovascular calcification

JRCT ID: jRCTs061180041

Registered date:08/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: aortic valve stenosis
• Date of first enrollment: 12/12/2017
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Combined PET/CT of the aortic valve and coronary plaque were performed within 1 month after cardiac CT imaging.
The patients were injected intravenously with a target dose of 185-370MBq 18F-NaF and rested in a quiet environment for 60 min. A non-enhanced CT scan for attenuation correction and a electrocardiogram-gated emission PET scan of the thorax were performed then.

Outcome(s)

• Primary Outcome: We compare 18F-Sodium Fluoride uptake of aortic valve, coronary artery, carotid artery and aorta on Positron Emission Tomography with coronary CT findings of aortic valve calcification, coronary calcification, and non-calcified and partial calcified plaques (positive remodeling, low attenuation plaque, spotty calcification and napkin-ring sign).

Secondary Outcome

We evaluate serial changes of aortic valve calcification on CT in 2-year period.
We classify 18F-NaF uptake pattern of aortic valve into three groups in relation to CT-based calcification; overlapping with calcification, adjacent to calcification and distant from calcification. Additionally, we evaluate the location of aortic valve calcification (valve leaflet or ring). We assess the progression of aortic valve calcification and aortic valve stenosis in relative to 18F-NaF uptake value and uptake pattern.

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

We include the patients with the following conditions.
1) Patients with coronary plaque (calcified plaque, non-calcified plaque and partial calcified plaque in >=2mm diameter coronary) or aortic valve calcification (CT value >=130HU) on coronary CT in Hiroshima University Hospital.
2) Patients over 30 years-old.
3) Patients without acute coronary syndrome and/or severe heart failure (within 3 months), or a unconscious condition.
4) Patients who agree with informed consent.

Exclude criteria

1) Patients with bad general conditions, for example, immediately after cerebral hemorrhage.
2) Pregnant and lactating females (include possibility of them).
3) Claustrophobic patients.
4) Patients who are judged unsuitable for this study by the person in charge.

Related Information

• Primary Sponsor: Nakano Yukiko
• Secondary ID(s): UMIN000031134