FDG an Myocardial Infarction: The PIAF Trial

Conditions

• History of Myocardial Infarction

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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 Dates

Start date

Dec 1, 2021

Status verified

Nov 2021

Primary completion

Jul 1, 2025

Completion

Jul 1, 2026

Study Design

Enrollment

2,041 participants (estimated)

Primary Outcome Measure

Cardiovascular events [ Time Frame: 4 to 5 years follow-up period ]

Central Contacts

• Francesco Giammarile, MD, PhD
  +436606820396
  [email protected]
• Diana Paez, MD
  +4316521670
  [email protected]

Locations (1)

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