Cardiovascular DiseasesPhase 4ROPPET-NAFNCT03233243
Rosuvastatin Effect on Atherosclerotic Plaque Metabolism
A Phase 4 study testing Rosuvastatin Oral Tablet in people with Cardiovascular Diseases and Atherosclerosis, run by University of Coimbra at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerosis, Molecular Imaging
- What is being tested?
- Rosuvastatin Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Jul 2020to 27 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 40 years;
- Written informed consent;
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar e Universitário de Coimbra
Coimbra, 3000-075
About this study
Official title: Rosuvastatin Effect on Atherosclerotic Plaque Metabolism - a Subclinical Atherosclerosis Imaging Study With 18F-NaF PET-CT
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.
Read the detailed description
Background:
Cardiovascular diseases (CVD) are the main cause of mortality in developed countries; its prevention is challenging. Advances in molecular imaging of the atherosclerotic plaque enhanced the study of its pathophysiology, including the positron emission tomography with computed tomography (PET-CT) scan. The marker 18F-sodium fluoride (NaF) has been studied in peripheral arteries plaque imaging as an in vivo marker of on-going calcification. The 18F ions deposit in the bone by exchange of hydroxyl group on the surface of the hydroxyapatite matrix to form fluoroapatite, so this tracer detects areas of active calcification and osteogenic remodeling. Coronary imaging with 18F-NaF labelled PET-CT was recently described and proposed to be able to discriminate between active and inactive coronary calcification, possibly identifying high-risk patients.
Statin therapy is approved for primary and secondary CVD prevention due to both its cholesterol-lowering effect and positive pleiotropic properties in the plaque. In particular, rosuvastatin diminishes mortality and vascular events when used in primary and secondary prevention. High doses of rosuvastatin resulted in atherosclerosis regression as assessed with coronary intravascular ultrasound, carotid intima-media thickness (CIMT) and lipid content reduction of the atherosclerotic plaque (near-infrared spectroscopy analysis).
We do not know the effects of statins in the 18F-NaF uptake.
Design:
Investigator's initiative prospective study of 18F-NaF-PET-CT coronary, aortic and carotid plaques imaging in primary prevention subjects, with a before and after experiment with rosuvastatin treatment and long-term follow-up. The protocol was approved by the Ethics Committee of Faculty of Medicine of the University of Coimbra and written according to Good Clinical Practice and the Declaration of Helsinki.
Taks:
- Screening - visit 0: Patients followed at the Arterial Hypertension clinic of Centro Hospitalar e Universitário de Coimbra will be screened and selected if they meet all of the inclusion criteria.
- Baseline assessment: Clinical questionnaire and standard physical examination. CV risk will be estimated according to SCORE equations and the American Heart Association atherosclerotic cardiovascular disease calculator. Patients' medical history and CV risk factors will be recorded, as well as physical examination findings, including age, race, gender, smoking status (current, past, quantification with pack-years), diabetes mellitus (type 1, 2, pre- diabetes), family history of premature coronary heart disease (first degree: men < 55 and women < 65 years old), relevant past medical history, blood pressure, heart rate, weight and height. Levels of total cholesterol, high and low-density lipoprotein cholesterol (HDL and LDL), triglycerides, creatinine, creatine kinase, alanine amino-transferase, aspartate amino- transferase, gamma-glutamyl transpeptidase, alkaline phosphatase, glycated hemoglobin, fasting glucose, high-sensitivity C-reactive protein and haemoglobin will be determined.
- Baseline 18F-NaF labelled PET-CT - visit 1: Patients will undergo whole body 18F-NaF-PET-CT for identification of coronary, carotid, thoracic and abdominal aorta arteries plaques and quantification of 18F-NaF uptake (tissue-to-background ratio (TBR)). Scans will be reviewed and analysed by experienced observers blinded to the clinical diagnosis. Subjects without 18F-NaF-positive plaques will be excluded from the pharmacological intervention study.
- Rosuvastatin treatment: At visit 1, patients with 18F-NaF-positive plaques will be treated with 20 mg of rosuvastatin daily for six months, except in patients who need a 55% LDL reduction to achieve recommended targets (rosuvastatin 40 mg).
- Second 18F-NaF labelled PET-CT - visit 3:
Subjects will undergo a second PET-CT scan six months after statin treatment to assess changes in 18F-NaF plaque uptake. Medication compliance will be monitored, as well as adverse events reporting.
Statistical analysis:
18F-NaF uptake after rosuvastatin treatment will be compared to baseline values with paired samples T student test or Wilcoxon text according to the normality of the distribution. Sample size was estimated according to the preliminary results of 25 subjects (pilot study) and the primary endpoint of reducing maximum 18F-NaF uptake as assessed by TBR. Individuals with no significant 18F-NaF uptake were excluded from this analysis (n=4): mean TBR 2.16 and SD 0.40. At 90% power and a significance level of 0.05, assuming a correlation of 0.8 and 10% difference in TBR, the calculated sample size is 32. As only 21 out of 25 subjects in the pilot study displayed criteria for the pharmacological study, it is necessary to perform 44 baseline studies, followed by 36 subjects re-evaluation (drop-out margin of 4 subjects), totaling 80 PET-CT scans.
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Molecular Imaging
- Being tested
- Rosuvastatin Oral Tablet
- Keywords
- Rosuvastatin, Sodium fluoride, Positron-emission tomography
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin Oral TabletDrug
Patients with 18F-NaF-positive plaques will be treated with 20 mg of rosuvastatin daily for six months, except in patients who need a 55% LDL reduction to achieve recommended targets (rosuvastatin 40 mg). A second visit (visit 2) will take place eight weeks after therapy initiation to monitor for compliance and adverse events report: therapy will be discontinued if there is an elevation of creatine kinase over five times the ULN with myalgia or alanine amino-transferase three times the ULN.
| Study group | Role | What they receive |
|---|---|---|
| Patients with positive 18F-NaF plaques | Experimental | Patients with 18F-NaF-positive plaques (coronary, aortic or carotid) with TBR > 1.5 Receives: Drug: Rosuvastatin Oral Tablet |
| Patients without 18F-NaF-positive plaques | No intervention | Subjects without 18F-NaF- positive plaques will be excluded from the pharmacological intervention study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start27 Jul 2020
- Primary completion20 Jun 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Manuel Oliveira Santos, University of Coimbra
- Investigators
- Miguel Castelo-Branco, PhD, Study director, Coimbra's University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233243
- Sponsor's protocol ID
- ICNAS-2016-01
- Acronym
- ROPPET-NAF
- Status last verified
- Oct 2022
- First submitted
- 25 Jul 2017
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22516444Joshi 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.
PubMed 24224999Blomberg BA, Thomassen A, de Jong PA, Simonsen JA, Lam MG, Nielsen AL, Mickley H, Mali WP, Alavi A, Hoilund-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.
PubMed 26205304Oliveira-Santos M, Castelo-Branco M, Silva R, Gomes A, Chichorro N, Abrunhosa A, Donato P, Pedroso de Lima J, Pego M, Goncalves L, Ferreira MJ. Atherosclerotic plaque metabolism in high cardiovascular risk subjects - A subclinical atherosclerosis imaging study with 18F-NaF PET-CT. Atherosclerosis. 2017 May;260:41-46. doi: 10.1016/j.atherosclerosis.2017.03.014. Epub 2017 Mar 10.
PubMed 28349887Ferreira MJV, Oliveira-Santos M, Silva R, Gomes A, Ferreira N, Abrunhosa A, Lima J, Pego M, Goncalves 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.
PubMed 28070735
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosuvastatin Effect on Atherosclerotic Plaque Metabolism - a Subclinical Atherosclerosis Imaging Study With 18F-NaF PET-CT
- ClinicalTrials.gov ID
- NCT03233243
- Acronym / sponsor ID
- ROPPET-NAF / ICNAS-2016-01
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Molecular Imaging
- Keywords
- Rosuvastatin, Sodium fluoride, Positron-emission tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Cardiovascular diseases (CVD) are the main cause of mortality in developed countries; its prevention is challenging. Advances in molecular imaging of the atherosclerotic plaque enhanced the study of its pathophysiology, including the positron emission tomography with computed tomography (PET-CT) scan. The marker 18F-sodium fluoride (NaF) has been studied in peripheral arteries plaque imaging as an in vivo marker of on-going calcification. The 18F ions deposit in the bone by exchange of hydroxyl group on the surface of the hydroxyapatite matrix to form fluoroapatite, so this tracer detects areas of active calcification and osteogenic remodeling. Coronary imaging with 18F-NaF labelled PET-CT was recently described and proposed to be able to discriminate between active and inactive coronary calcification, possibly identifying high-risk patients.
Statin therapy is approved for primary and secondary CVD prevention due to both its cholesterol-lowering effect and positive pleiotropic properties in the plaque. In particular, rosuvastatin diminishes mortality and vascular events when used in primary and secondary prevention. High doses of rosuvastatin resulted in atherosclerosis regression as assessed with coronary intravascular ultrasound, carotid intima-media thickness (CIMT) and lipid content reduction of the atherosclerotic plaque (near-infrared spectroscopy analysis).
We do not know the effects of statins in the 18F-NaF uptake.
Design:
Investigator's initiative prospective study of 18F-NaF-PET-CT coronary, aortic and carotid plaques imaging in primary prevention subjects, with a before and after experiment with rosuvastatin treatment and long-term follow-up. The protocol was approved by the Ethics Committee of Faculty of Medicine of the University of Coimbra and written according to Good Clinical Practice and the Declaration of Helsinki.
Taks:
- Screening - visit 0: Patients followed at the Arterial Hypertension clinic of Centro Hospitalar e Universitário de Coimbra will be screened and selected if they meet all of the inclusion criteria.
- Baseline assessment: Clinical questionnaire and standard physical examination. CV risk will be estimated according to SCORE equations and the American Heart Association atherosclerotic cardiovascular disease calculator. Patients' medical history and CV risk factors will be recorded, as well as physical examination findings, including age, race, gender, smoking status (current, past, quantification with pack-years), diabetes mellitus (type 1, 2, pre- diabetes), family history of premature coronary heart disease (first degree: men < 55 and women < 65 years old), relevant past medical history, blood pressure, heart rate, weight and height. Levels of total cholesterol, high and low-density lipoprotein cholesterol (HDL and LDL), triglycerides, creatinine, creatine kinase, alanine amino-transferase, aspartate amino- transferase, gamma-glutamyl transpeptidase, alkaline phosphatase, glycated hemoglobin, fasting glucose, high-sensitivity C-reactive protein and haemoglobin will be determined.
- Baseline 18F-NaF labelled PET-CT - visit 1: Patients will undergo whole body 18F-NaF-PET-CT for identification of coronary, carotid, thoracic and abdominal aorta arteries plaques and quantification of 18F-NaF uptake (tissue-to-background ratio (TBR)). Scans will be reviewed and analysed by experienced observers blinded to the clinical diagnosis. Subjects without 18F-NaF-positive plaques will be excluded from the pharmacological intervention study.
- Rosuvastatin treatment: At visit 1, patients with 18F-NaF-positive plaques will be treated with 20 mg of rosuvastatin daily for six months, except in patients who need a 55% LDL reduction to achieve recommended targets (rosuvastatin 40 mg).
- Second 18F-NaF labelled PET-CT - visit 3:
Subjects will undergo a second PET-CT scan six months after statin treatment to assess changes in 18F-NaF plaque uptake. Medication compliance will be monitored, as well as adverse events reporting.
Statistical analysis:
18F-NaF uptake after rosuvastatin treatment will be compared to baseline values with paired samples T student test or Wilcoxon text according to the normality of the distribution. Sample size was estimated according to the preliminary results of 25 subjects (pilot study) and the primary endpoint of reducing maximum 18F-NaF uptake as assessed by TBR. Individuals with no significant 18F-NaF uptake were excluded from this analysis (n=4): mean TBR 2.16 and SD 0.40. At 90% power and a significance level of 0.05, assuming a correlation of 0.8 and 10% difference in TBR, the calculated sample size is 32. As only 21 out of 25 subjects in the pilot study displayed criteria for the pharmacological study, it is necessary to perform 44 baseline studies, followed by 36 subjects re-evaluation (drop-out margin of 4 subjects), totaling 80 PET-CT scans.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with positive 18F-NaF plaques | Experimental | Drug: Rosuvastatin Oral TabletPatients with 18F-NaF-positive plaques (coronary, aortic or carotid) with TBR > 1.5 |
| Patients without 18F-NaF-positive plaques | No intervention | –Subjects without 18F-NaF- positive plaques will be excluded from the pharmacological intervention study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than 40 years;
- Written informed consent;
- Considered to be at high or very high CV risk according to the European Society of Cardiology guidelines, fulfilling any of the following criteria:
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin Oral TabletPatients with 18F-NaF-positive plaques will be treated with 20 mg of rosuvastatin daily for six months, except in patients who need a 55% LDL reduction to achieve recommended targets (rosuvastatin 40 mg). A second visit (visit 2) will take place eight weeks after therapy initiation to monitor for compliance and adverse events report: therapy will be discontinued if there is an elevation of creatine kinase over five times the ULN with myalgia or alanine amino-transferase three times the ULN. | Drug | Patients with positive 18F-NaF plaques |
Primary outcome
Variation in 18F-NaF uptake in coronary, aortic and carotid plaques (tissue to background ratio - TBR)
Time frame: 6 months
* 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)
1 secondary outcome
Variation in 18F-NaF uptake in coronary, aortic and carotid plaques (corrected uptake per lesion - CUL)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Background: PubMed 22516444Dweck 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.
- Background: PubMed 24224999Joshi 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.
- Background: PubMed 26205304Blomberg BA, Thomassen A, de Jong PA, Simonsen JA, Lam MG, Nielsen AL, Mickley H, Mali WP, Alavi A, Hoilund-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.
- Background: PubMed 28349887Oliveira-Santos M, Castelo-Branco M, Silva R, Gomes A, Chichorro N, Abrunhosa A, Donato P, Pedroso de Lima J, Pego M, Goncalves L, Ferreira MJ. Atherosclerotic plaque metabolism in high cardiovascular risk subjects - A subclinical atherosclerosis imaging study with 18F-NaF PET-CT. Atherosclerosis. 2017 May;260:41-46. doi: 10.1016/j.atherosclerosis.2017.03.014. Epub 2017 Mar 10.
- Background: PubMed 28070735Ferreira MJV, Oliveira-Santos M, Silva R, Gomes A, Ferreira N, Abrunhosa A, Lima J, Pego M, Goncalves 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Castelo-Branco, PhD study director
Coimbra's University - Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin Oral Tablet in people with Cardiovascular Diseases and Atherosclerosis, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in 18F-NaF uptake in coronary, aortic and carotid plaques (tissue to background ratio - TBR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03233243, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.