Clinical trial NCT01749254: Novel Imaging Approaches To Identify Unstable Coronary Plaques
Official title: Novel Imaging Approaches To Identify Unstable Coronary Plaques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Culprit plaques
Vulnerable Plaques
PET
calcification
inflammation
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2012-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Patients with ACS have focal 18F-NaF uptake and high tissue to background ratio(TBR) and standardised uptake values (SUV) in the culprit vessels.
timeFrame: Within 1 month of index event
measure: What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value
timeFrame: 1 month
Secondary outcomes:
measure: 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.
timeFrame: 1 month
Other outcomes:
measure: Is there a difference between the coronary and aortic TBR/SUVs in stable and unstable patients
timeFrame: 1 month
measure: Will patients with higher 18F-NaF uptake as measured by SUV/TBR will have higher levels of cardiac biomarkers such as hsCRP or Troponin
timeFrame: 1 year
Locations:
city: Edinburgh
country: United Kingdom
facility: Clinical Research Imaging Centre/ NHS LOTHIAN
state: Midlothian
Study officials:
References:
citation: Joshi NV, Toor I, Shah AS, Carruthers K, Vesey AT, Alam SR, Sills A, Hoo TY, Melville AJ, Langlands SP, Jenkins WS, Uren NG, Mills NL, Fletcher AM, van Beek EJ, Rudd JH, Fox KA, Dweck MR, Newby DE. Systemic Atherosclerotic Inflammation Following Acute Myocardial Infarction: Myocardial Infarction Begets Myocardial Infarction. J Am Heart Assoc. 2015 Aug 27;4(9):e001956. doi: 10.1161/JAHA.115.001956.