Novel Imaging Approaches To Identify Unstable Coronary Plaques
Recruitment status was Recruiting
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.
Coronary Artery Disease
|Study Design:||Time Perspective: Prospective|
|Official Title:||Novel Imaging Approaches To Identify Unstable Coronary Plaques|
- Patients with ACS have focal 18F-NaF uptake and high tissue to background ratio(TBR) and standardised uptake values (SUV) in the culprit vessels. [ Time Frame: Within 1 month of index event ] [ Designated as safety issue: No ]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.
- What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value [ Time Frame: 1 month ] [ Designated as safety issue: No ]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
- 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 ] [ Designated as safety issue: No ]
- Is there a difference between the coronary and aortic TBR/SUVs in stable and unstable patients [ Time Frame: 1 month ] [ Designated as safety issue: No ]The investigators will look for differences in activity in stable angina and ACS patients using 18F-NaF and 18F-FDG
- Will patients with higher 18F-NaF uptake as measured by SUV/TBR will have higher levels of cardiac biomarkers such as hsCRP or Troponin [ Time Frame: 1 year ] [ Designated as safety issue: No ]Blood collected from volunteers in the study will be analysed for inflammatory biomarkers such as hsCRP and Troponin
|Study Start Date:||February 2012|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Acute Coronary Syndrome
40 patients admitted with ACS (NSTEMI/STEMI) will be recruited undergo 18F NaF PET, 18F FDG and CTCA within 1 month of the event.
Stable angina cohort
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749254
|Clinical Research Imaging Centre/ NHS LOTHIAN||Recruiting|
|Edinburgh, Midlothian, United Kingdom, EH16 4SB|
|Contact: DAVID NEWBY, MD PHD 0131 242 6515 email@example.com|
|Principal Investigator: Nikhil Joshi, MD|