An observational study in Coronary Artery Disease, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by University of Edinburgh · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 80 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The investigators will recruit two populations of 40 patients each. The first population will be patients with known stable coronary heart disease. They will have previously documented and angiographically proven coronary artery disease (≥70% luminal stenosis of a major epicardial vessel). The second population will be patients with a recent (within 30 days) acute myocardial infarction defined by the Universal definition of myocardial infarction. The culprit plaque will be defined according to the invasive coronary angiogram appearances, electrocardiogram and clinical features by two cardiologists blinded to the results of positron emission tomography.
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).
40 patients admitted with ACS (NSTEMI/STEMI) will be recruited undergo 18F NaF PET, 18F FDG and CTCA within 1 month of the event.
40 patients with previously diagnosed coronary artery disease and listed to undergo elective coronary angiogram will be recruited. VH-IVUS will be attempted in all patients. Selected patients will undergo PET scan after stent implantation.
Patients with ACS have focal 18F-NaF uptake and high tissue to background ratio(TBR) and standardised uptake values (SUV) in the culprit vessels.
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: Within 1 month of index event
What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value
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
Is there a co-relation between the two PET/CT tracers(18FDG and 18F NaF) as measured as Tissue to background ratio or standardised uptake value.
Time frame: 1 month
Is there a difference between the coronary and aortic TBR/SUVs in stable and unstable patients
The investigators will look for differences in activity in stable angina and ACS patients using 18F-NaF and 18F-FDG
Time frame: 1 month
Will patients with higher 18F-NaF uptake as measured by SUV/TBR will have higher levels of cardiac biomarkers such as hsCRP or Troponin
Blood collected from volunteers in the study will be analysed for inflammatory biomarkers such as hsCRP and Troponin
Time frame: 1 year
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Edinburgh