Cardiovascular Diseases Clinical Trial
— ROPPET-NAFOfficial title:
Rosuvastatin Effect on Atherosclerotic Plaque Metabolism - a Subclinical Atherosclerosis Imaging Study With 18F-NaF PET-CT
Verified date | October 2022 |
Source | University of Coimbra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Atherosclerotic plaque uptake of 18F-sodium fluoride (NaF) in positron emission tomography with computed tomography (PET-CT) was recently shown to correlate with clinical instability in patients with CV disease. We hypothesize that rosuvastatin reduces 18F-NaF plaque uptake. Our group will scan coronary, aortic and carotid arteries of high-risk CV subjects with 18F- NaF-PET-CT. Individuals with 18F-NaF-positive plaques will be treated with rosuvastatin for six months, followed by 18F-NaF-PET-CT re-evaluation.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 27, 2022 |
Est. primary completion date | June 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Older than 40 years; 2. Written informed consent; 3. Considered to be at high or very high CV risk according to the European Society of Cardiology guidelines, fulfilling any of the following criteria: - predicted fatal CV event at 10 years =5% (SCORE tables for low-risk countries); - chronic kidney disease with glomerular filtration rate (GFR) under 60 mL/min (Modification of Diet in Renal Disease equation - MDRD); - diabetes mellitus (type 1 or 2); - markedly elevated single risk factors. Exclusion Criteria: - Previous CV events; - GFR under 30 mL/min; - Known hepatic dysfunction or alanine amino-transferase level more than twice the upper limit of the normal (ULN) range; - Creatine kinase level more than three times the ULN; - Known myopathy; - Statin hypersensivity; - Hormone replacement therapy; - Malignant neoplasms in the past five years (excluding basal-cell skin carcinoma); - Uncontrolled hypothyroidism; - Chronic inflammatory disease (such as rheumatoid arthritis, inflammatory bowel disease); - Pregnancy or women in child bearing age without contraceptive; |
Country | Name | City | State |
---|---|---|---|
Portugal | Centro Hospitalar e Universitário de Coimbra | Coimbra |
Lead Sponsor | Collaborator |
---|---|
University of Coimbra | AstraZeneca |
Portugal,
Blomberg BA, Thomassen A, de Jong PA, Simonsen JA, Lam MG, Nielsen AL, Mickley H, Mali WP, Alavi A, Høilund-Carlsen PF. Impact of Personal Characteristics and Technical Factors on Quantification of Sodium 18F-Fluoride Uptake in Human Arteries: Prospective Evaluation of Healthy Subjects. J Nucl Med. 2015 Oct;56(10):1534-40. doi: 10.2967/jnumed.115.159798. Epub 2015 Jul 23. — View Citation
Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037. — View Citation
Ferreira MJV, Oliveira-Santos M, Silva R, Gomes A, Ferreira N, Abrunhosa A, Lima J, Pego M, Gonçalves L, Castelo-Branco M. Assessment of atherosclerotic plaque calcification using F18-NaF PET-CT. J Nucl Cardiol. 2018 Oct;25(5):1733-1741. doi: 10.1007/s12350-016-0776-9. Epub 2017 Jan 9. — View Citation
Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11. — View Citation
Oliveira-Santos M, Castelo-Branco M, Silva R, Gomes A, Chichorro N, Abrunhosa A, Donato P, Pedroso de Lima J, Pego M, Gonçalves L, Ferreira MJ. Atherosclerotic plaque metabolism in high cardiovascular risk subjects - A subclinical atherosclerosis imaging study with (18)F-NaF PET-CT. Atherosclerosis. 2017 May;260:41-46. doi: 10.1016/j.atherosclerosis.2017.03.014. Epub 2017 Mar 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety outcome | Adverse events monitoring related with medical treatment namely statins: myalgia, myopathy (CK), hepatotoxicity (ALT), gastrointestinal symptoms. | 6 months | |
Primary | Variation in 18F-NaF uptake in coronary, aortic and carotid plaques (tissue to background ratio - TBR) | Whole body 18F-NaF-PET-CT for identification of coronary, carotid, thoracic and abdominal aorta arteries plaques:
administration of 125 MBq 18F-NaF intravenously, followed by an attenuation correction CT scan and PET imaging after 60 min. Coronary images will be reconstructed according with the usual protocol of PET-CT. Two-dimensional regions of interest will be drawn around all major epicardial coronary vessels and around the major vessels on three millimetres axial slices. Quantification of 18F-NaF uptake at baseline and after optimal treatment including statins: ratio of the maximum standard uptake value (SUV) in the region of interest (the decay corrected tissue concentration of the tracer divided by the injected dose per bodyweight) and blood pool activity in the superior vena cava: tissue-to-background ratio (TBR). Primary outcome: variation in maximum TBR at any vascular territory (coronary, carotid or aortic) |
6 months | |
Secondary | Variation in 18F-NaF uptake in coronary, aortic and carotid plaques (corrected uptake per lesion - CUL) | Quantification of 18F-NaF uptake at baseline and after optimal medical treatment
difference between the maximum SUV in the region of interest and blood pool activity in the superior vena cava: corrected uptake per lesion - CUL. Primary outcome: variation in maximum CUL at any vascular territory (coronary, carotid or aorta) |
6 months |
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