FDG an Myocardial Infarction: The PIAF Trial

Status unconfirmed

Conditions studied: History of Myocardial Infarction

In brief

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.

Key facts

Study ID: NCT05138718
Run by: International Atomic Energy Agency
People needed: 2041
Starts: 2021-12-01
Expected to finish: 2026-07-01
Last updated by the study team: 2021-12-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 reached, patients who undergo FDG PET/CT imaging for cancer screening or surveillance can be included, provided that they have no evidence of an active malignancy on the scan or other exclusion criteria as listed below at study entry, including recent radio- and / or chemotherapy (≥ 12 months before the FDG PET/CT)

You may not qualify if…

Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema)
Extra-cardiac illness that is expected to limit survival to less than 4-5 years; e. g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or severe hepatic dysfunction, severe renal disease, active cancer
Patients with chronic use of anti-inflammatory medication (except NSAIDs and inhaled corticosteroids)
Patients with Diabetes Type I
Insulin-dependent or uncontrolled Diabetes Type II (as HbA1C>7.5)
Withdrawal of Informed consent

Where it is running

Massachusetts General Hospital, Havard Medical School — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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