International Multicenter Trial on the Prognostic Value of Arterial 18F-FDG PET Imaging in Patients With History of Myocardial Infarction
International Atomic Energy Agency
Summary
In order to define distinct and reliable arterial 18Fluorodeoxyglucose (FDG) thresholds identifying patients at risk for cardiovascular events, patients with a history of myocardial infarction will be included in this international multicenter 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) and different brain regions (e. g. amygdala) will be measured. Furthermore, specific blood biomarkers including genetic biomarkers, which are linked to atherosclerotic disease with predictive power for future cardiovascular events, will be analyzed in a subgroup of patients. In part 2 of the trial, a 4-year follow-up period will be analyzed with a focus on the prediction of 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). 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.
Description
From a clinical perspective, atherosclerosis leading to arterial plaque rupture is one of the most important causes of death that still misses a personalized, reliable and quantitative assessment of risk. This is particularly true for patients who suffered from a non-fatal coronary syndrome, were recent studies described severe CVD event rates of up to 5 % per year despite the use of aggressive secondary prevention strategies. While in previous clinical interventional trials inflammatory atherosclerotic activity was mainly determined by the surrogate marker high-sensitivity C-reactive protein…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willing and able to provide written informed consent * Patients 18-80 years of age * Patients with documented myocardial infarction \> 90 days before study inclusion * Clinically stable at the time of screening and able to tolerate the study procedure * Female patients must not be pregnant at the time of FDG PET/CT imaging * Patients included in other clinical trials could be included, provided this complies with specific local and research center requirements * If after 6 months of patient recruitment it is foreseeable that the target number of patients will not be reac…
Interventions
- Diagnostic Test18F-FDG PET/CT
Perform a 18F-FDG PET/CT to patients with history of myocardial infarction
Location
- Massachusetts General Hospital, Havard Medical SchoolBoston, Massachusetts