NCT01724749

Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT

Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT: The CAMONA Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 144 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular molecular calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron emission tomography (PET) computed tomography (CT) in a prospective cohort of healthy control subjects and subjects with cardiovascular disease.

Detailed description

Atherosclerosis associated cardiovascular disease (CVD) remains a significant cause of morbidity and mortality. Asymptomatic individuals with a moderate to high-risk of developing acute atherosclerotic cardiovascular events will benefit most from intensive evidence-based medical interventions. The traditional approach to identify patients with moderate to high-risk of CVD involves quantifying the presence of CVD risk factors. Based on gender, age, smoking, systolic blood pressure and cholesterol levels, risk stratification algorithms such as the Framingham Risk Score (FRS) and the European SCORE system can predict the 10-year risk of cardiovascular death. However, these algorithms are associated with several limitations, including misclassification of women and individuals with high levels of a single risk factor. The risk is underestimated in these individuals. Therefore, these individuals are not eligible for treatment by current criteria of CVD prevention guidelines. Several studies indicate that the traditional risk score models leave room for improvement, as they work reasonably well for populations, but remain suboptimal for individual subjects. New risk parameters are discovered on a regular basis. One of these parameters is cardiovascular molecular calcification (CMC). This entity can be detected and quantified by 18F-NaF PET CT. It has been hypothesized that CMC can be detected years, maybe even decades, before coronary artery calcium scoring (CACS) can be detected by conventional imaging modalities like multislice CT. Theoretically, this tool can detect patients at a very early stage of the disease. Providing evidence-based treatment to these individuals can, theoretically, improve the prevention of CVD. Before this hypothesises can be tested, the feasibility of 18F-NaF PET CT has to be demonstrated in both healthy controls as well as in subjects with cardiovascular disease.

Conditions

• Cardiovascular Disease
• Atherosclerosis
• Angina Pectoris

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-11-01
• Completion: 2016-12-01
• First posted: 2012-11-12
• Last updated: 2012-11-12

Locations

2 sites across 1 country: Denmark