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          Prognostic Value of Arterial 18F-FDG PET Imaging - The PIAF Trial

          Closed for proposals

          Project Type

          Coordinated Research Project

          Project Code

          E13048

          CRP

          2198

          Approved Date

          11 December 2018

          Status

          Active - Ongoing

          Start Date

          9 May 2019

          Expected End Date

          9 May 2026

          Participating Countries

          Argentina
          Australia
          Austria
          Brazil
          China
          Croatia
          Germany
          India
          Iran (Islamic Republic of)
          Israel
          Italy
          Pakistan
          Republic of Korea
          Serbia
          Thailand
          United States of America

          Description

          In order to define distinct and reliable arterial 18 Fluor Desoxyglucose (FDG) thresholds identifying patients at risk for cardiovascular events, patients with a history of myocardial infarction and elevated high-sensitivity C-reactive protein (hsCRP) will be included in this international multicentre trial. Non-enhanced whole-body FDG PET/CT will be performed in all patients and the arterial FDG uptake in the carotid arteries as well as the aorta will be quantified by calculating different uptake parameters. In addition FDG uptake in hematopoietic tissues (spleen, bone marrow), visceral adipose tissue (VAT) as well as different brain regions (e. g. amygdala).Furthermore, specific blood biomarkers including genetic biomarkers, which are linked to atherosclerotic disease with predictive power for future cardiovascular events will be analysed. Within a 4-year follow-up period, cardiovascular events (acute coronary syndrome, non-fatal ischemic stroke, ischemic cardiac death, other causes of death, coronary/vascular revascularization, new-onset of angina, symptomatic peripheral arterial disease and heart failure) will be recorded. The predictive value of the arterial, hematopoietic and cerebral FDG uptake parameters as well as of the specific blood and genetic biomarkers will be determined. Based on those results, a novel diagnostic algorithm in patients at risk for atherosclerosis and consequently emerging cardiovascular events including FDG PET/CT scan imaging will be defined.

          Objectives

          Test the hypothesis that the baseline measures of arterial inflammation (as assessed by FDG PET/CT) independently predicts the risk of subsequent clinically relevant CV events in a large cohort of individuals at increased risk.

          Specific objectives

          Evaluate the incremental prognostic value of arterial inflammation (PET/CT) over existing biomarkers.

          Evaluate the prognostic value of inflammation data derived from various arterial locations (e.g. aorta, carotids, or other locations) for their ability to predict CV events

          Identify cut-off values that indicate higher risk.

          Evaluate the inter-observer variability between study sites and core-lab.

          Evaluate the detection rate of incidental PET/CT findings in the study cohort (suspected malignancies, other diseases).

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