Rosuvastatin Effect on Atherosclerotic Plaque Metabolism (ROPPET-NAF)
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|ClinicalTrials.gov Identifier: NCT03233243|
Recruitment Status : Not yet recruiting
First Posted : July 28, 2017
Last Update Posted : October 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Atherosclerosis Molecular Imaging||Drug: Rosuvastatin Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Rosuvastatin Effect on Atherosclerotic Plaque Metabolism - a Subclinical Atherosclerosis Imaging Study With 18F-NaF PET-CT|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||May 1, 2021|
Experimental: Patients with positive 18F-NaF plaques
Patients with 18F-NaF-positive plaques (coronary, aortic or carotid) with TBR > 1.5
Drug: Rosuvastatin Oral Tablet
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.
No Intervention: Patients without 18F-NaF-positive plaques
Subjects without 18F-NaF- positive plaques will be excluded from the pharmacological intervention study
- 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)
- Variation in 18F-NaF uptake in coronary, aortic and carotid plaques (corrected uptake per lesion - CUL) [ Time Frame: 6 months ]
- 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)
- Safety outcome [ Time Frame: 6 months ]Adverse events monitoring related with medical treatment namely statins: myalgia, myopathy (CK), hepatotoxicity (ALT), gastrointestinal symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233243
|Contact: Manuel Oliveira Santos, MDfirstname.lastname@example.org|
|Contact: Maria João Vidigal Ferreira, PhDemail@example.com|
|Study Director:||Miguel Castelo-Branco, PhD||Coimbra's University - Faculty of Medicine|