RecruitingNCT05138718

FDG an Myocardial Infarction: The PIAF Trial

International Multicenter Trial on the Prognostic Value of Arterial 18F-FDG PET Imaging in Patients With History of Myocardial Infarction


Sponsor

International Atomic Energy Agency

Enrollment

2,041 participants

Start Date

Dec 1, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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

Exclusion Criteria6

  • 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

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Interventions

DIAGNOSTIC_TEST18F-FDG PET/CT

Perform a 18F-FDG PET/CT to patients with history of myocardial infarction


Locations(1)

Massachusetts General Hospital, Havard Medical School

Boston, Massachusetts, United States

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NCT05138718