Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT (CAMONA)

Odense University Hospital

Status: Unknown

Conditions: Angina Pectoris; Atherosclerosis; Cardiovascular Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01724749

s-20120056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 21 - 80 years
• Healthy controls: No prior history or symptoms of cardiovascular disease
• Cardiology subjects: Eligibility for CACS due to symptoms suggesting angina pectoris.
• Cardiology subjects: HeartSCORE > 0%.

Exclusion criteria

• Pregnancy
• Extensive physical activity or extensive partying passed 24 hours
• History of malignant neoplasms with past 5 years
• Known immunodeficiencies
• History of deep vein thrombosis or acute pulmonary embolism within the previous three months
• History of alcohol abuses, illicit drug use, or drug abuse, or significant mental illness
• Initiation of statin-therapy within 3 months prior to consideration of study enrolment
• History of autoimmune disease, such as systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.
• Participation in any clinical trial of an investigational drug, device, or medical procedure within 30 days prior to baseline of the study
• Enrolment or planned enrolment in another clinical trial during the study period

Trial design

144 participants in 2 patient groups

Healthy control subjects

Description:

1. Age: 21 - 80 years 2. No prior history or symptoms of cardiovascular disease The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80.

Subjects with cardiovascular disease

Description:

1. Age: 21 - 80 years 2. HeartSCORE \> 0% 3. Symptoms of angina pectoris The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80. Also, the investigators aim to include patients in 3 strata of HeartSCORE risk: low risk (1-4%), mild risk (5-9%) and high risk (\> 9%)