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临床试验/NCT01724749
NCT01724749Unknown不适用

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

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
144
试验地点
2
主要终点
Standardized uptake value (SUV) of 18F-NaF

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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%.

排除标准

  • 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

结局指标

主要结局

Standardized uptake value (SUV) of 18F-NaF

时间窗: Up to 7 days after the day of PET CT acquisition

The SUV is a validated semi-quantitative assessment of PET radiotracer uptake. The SUV of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.

Target to background ratio (TBR) of 18F-NaF

时间窗: Up to 7 days after the day of PET CT acquisition

The TBR is a validated semi-quantitative assessment of PET radiotracer uptake. The TBR of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.

次要结局

  • Correlations between 18F-NaF TBR, 18F-FDG TBR, and CT calcification scoring(Up to 7 days after the day of PET CT acquisition)
  • Target to background ratio (TBR) of 18F-NaF(Up to 7 days after the day of PET CT acquisition)
  • Correlation between 18F-NaF / 18F-FDG uptake and 18F-FDG uptake in the brain(Up to 7 days after the day of PET CT acquisition)
  • Correlation between the TBR of 18F-NaF/18F-FDG and traditional cardiovascular risk factors.(The cardiovascular risk factors will be determined, on average, 1 hour before 18F-NaF / 18F-FDG injection; which ever comes first)
  • Standardized uptake value (SUV) of 18F-Fluorodeoxyglucose (18F-FDG)(Up to 7 days after the day of PET CT acquisition)
  • Target to background ratio (TBR) of 18F-FDG(Up to 7 days after the day of PET CT acquisition)
  • Correlation between the TBR of 18F-NaF/18F-FDG and blood markers of atherosclerosis.(The blood draw will be performed, on average, 1 hour before the 18F-FDG PET CT scan and the blood markers will determined in upto 48 hours after the 18F-FDG PET CT scan)
  • Correlation between 18F-NaF TBR and 18F-NaF TBR two years after the baseline scan.(2 years)
  • Correlation between 18F-FDG TBR and 18F-FDG TBR two years after the baseline scan.(2 years)
  • Correlation between the TBR of 18F-NaF/18F-FDG and HeartSCORE(Up to 7 days after the day of PET CT acquisition)
  • Correlation between the TBR of 18F-NaF/18F-FDG and Framingham Risk Score(Up to 7 days after the day of PET CT acquisition)
  • Correlation between 18F-NaF / 18F-FDG uptake and 18F-NaF / 18F-FDG uptake in the vertebral body(Up to 7 days after the day of PET CT acquisition)
  • Arterial Calcification Score(Up to 7 days after the day of PET CT acquisition)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Björn A Blomberg

MD, MSc

Odense University Hospital

研究点 (2)

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