Submitted by Mi.Varokky@iaea.org on
Project Code
E13048
2198
IAEA Programme
Project Author
INTERNATIONAL ATOMIC ENERGY AGENCY
Approved Date
Start Date
Expected End Date
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).

Participating Countries
Argentina
Austria
Australia
Brazil
China
Germany
Croatia
Israel
India
Iran, Islamic Republic of
Republic of Korea
Pakistan
Serbia
Thailand
United States of America
CRP PO1 Name
GIAMMARILE,Francesco
CRP PO1 Email
F.Giammarile@iaea.org
CRP PO1 Section
NMDI - Nuclear Medicine and Diagnostic Imaging Section
CRP PO1 Division
NAHU - Division of Human Health
CRP PO2 Name
PAEZ,Diana
CRP PO2 Email
D.Paez@iaea.org
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