Actively Recruiting
FDG an Myocardial Infarction: The PIAF Trial
Led by International Atomic Energy Agency · Updated on 2021-12-01
2041
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FDG an Myocardial Infarction: The PIAF Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 may be included if allowed by local requirements
- If recruitment is slow, patients undergoing FDG PET/CT for cancer screening without active malignancy or recent chemo/radiotherapy (≥ 12 months) may be included
You will not qualify if you...
- Severe congestive heart failure (NYHA class III or IV, or pulmonary edema)
- Extra-cardiac illness expected to limit survival to less than 4-5 years (e.g., oxygen-dependent COPD, active hepatitis or severe liver dysfunction, severe renal disease, active cancer)
- Chronic use of anti-inflammatory medication except NSAIDs and inhaled corticosteroids
- Diabetes Type I
- Insulin-dependent or uncontrolled Diabetes Type II (HbA1C > 7.5)
- Withdrawal of informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital, Havard Medical School
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
F
Francesco Giammarile, MD, PhD
CONTACT
D
Diana Paez, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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