Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT
NCT ID: NCT01724749
Last Updated: 2012-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
144 participants
OBSERVATIONAL
2012-11-30
2016-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy control subjects
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.
No interventions assigned to this group
Subjects with cardiovascular disease
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%)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
80 Years
ALL
Yes
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Björn A Blomberg
MD, MSc
Principal Investigators
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Poul F Høilund-Carlsen, MD, DMSc
Role: STUDY_CHAIR
Odense University Hospital
Björn A Blomberg, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Department of Cardiology, Odense University Hospital
Odense, Region Syddanmark, Denmark
Department of Nuclear Medicine, Odense University Hospital
Odense, Region Syddanmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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Axel Diederichsen, MD
Role: primary
Poul F Høilund-Carlsen, MD, DMSc
Role: primary
References
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Patil S, Kata R, Teichner E, Subtirelu R, Ghonim M, Ghonim M, Al-Daoud O, Ismoilov M, Herpin L, Ayubcha C, Werner T, Hoilund-Carlsen PF, Alavi A. Associations of subclinical microcalcification and inflammation with carotid atheroma development: a dual-tracer PET/CT study. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2502-2512. doi: 10.1007/s00259-025-07127-z. Epub 2025 Feb 13.
Sorci O, Batzdorf AS, Mayer M, Rhodes S, Peng M, Jankelovits AR, Hornyak JN, Gerke O, Hoilund-Carlsen PF, Alavi A, Rajapakse CS. 18F-sodium fluoride PET/CT provides prognostic clarity compared to calcium and Framingham risk scoring when addressing whole-heart arterial calcification. Eur J Nucl Med Mol Imaging. 2020 Jul;47(7):1678-1687. doi: 10.1007/s00259-019-04590-3. Epub 2019 Nov 16.
Pourhassan Shamchi S, Khosravi M, Taghvaei R, Zirakchian Zadeh M, Paydary K, Emamzadehfard S, Werner TJ, Hoilund-Carlsen PF, Alavi A. Normal patterns of regional brain 18F-FDG uptake in normal aging. Hell J Nucl Med. 2018 Sep-Dec;21(3):175-180. doi: 10.1967/s002449910902. Epub 2018 Nov 10.
Other Identifiers
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s-20120056
Identifier Type: -
Identifier Source: org_study_id