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

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Project Type

Coordinated Research Project

Project Code

E13048

CRP

2198

Approved Date

2018/12/11

Status

3 - Active - Ongoing

Start Date

2019/05/09

Expected End Date

2024/05/09

Participating Countries

Argentina
Australia
Bosnia and Herzegovina
Brazil
China
Croatia
Germany
India
Israel
Italy
Pakistan
Serbia
Thailand

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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