Clinical Research Imaging Centre/ NHS LOTHIAN
Edinburgh, Midlothian, EH16 4SB, United Kingdom
NCT Number: NCT01749254
Cardiovascular disease is the leading cause of death in Scotland and the Western World. Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic plaques are urgently needed to help risk stratification, to identify patients for intensive therapies, and to provide novel biomarkers for the development of anti-atherosclerotic drug interventions. Using positron emission tomography, we have recently shown that sodium 18-fluoride uptake holds major promise as a novel marker of plaque vulnerability and rupture. Here we wish to characterise coronary atherosclerotic plaque using 128-multidetector computed tomography combined with 18-fluorodeoxyglucose and sodium 18-fluoride positron emission tomography and Virtual histology-intravascular ultrasound in 80 patients with stable and unstable coronary artery disease. This has the potential to provide an innovative and highly valuable translational model with which to test novel therapeutic interventions targeted at reducing atheroma and plaque rupture. This could have major implications for the future treatment of cardiovascular disease.
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Notify Me50 year and older
All sexes
Observational
Edinburgh, Midlothian, EH16 4SB, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age > or = 50 yrs. Patients with Acute coronary syndromes or stable coronary artery disease.
Exclusion criteria
Insulin dependent diabetes Inability or unwillingness to undergo computed tomography scanning Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min) Known contrast allergy Inability to give informed consent. Females in child bearing age will undergo pregnancy test if pregnancy suspected.
Participation in other research studies requiring exposure to further radiation (over and above mentioned in this study).
Time frame: Within 1 month of index event
Using PET/CT, the investigators will assess if there is presence of focal uptake at the areas of plaque ruptures in patients presenting with ACS. Standardised uptake values and Tissue to Background ratios of the culprit vessels with be compared with non-culprit lesions.
Time frame: 1 month
Using VH-IVUS, the investigators will look at the morphological characteristics of plaques that have higher SUVs and TBRs. Additional information about the plaque characteristics will be derived from CT coronary angiogram
Time frame: 1 month
Time frame: 1 month
The investigators will look for differences in activity in stable angina and ACS patients using 18F-NaF and 18F-FDG
Time frame: 1 year
Blood collected from volunteers in the study will be analysed for inflammatory biomarkers such as hsCRP and Troponin
University of Edinburgh
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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