RECRUITING

FDG an Myocardial Infarction: The PIAF Trial

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-01

Study Completion:2026-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05138718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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)	* 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

Inclusion Criteria

Exclusion 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 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)

* 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

Contacts and Locations

Study Contact

Francesco Giammarile, MD, PhD

CONTACT

+436606820396

f.giammarile@iaea.org

Diana Paez, MD

CONTACT

+4316521670

d.paez@iaea.org

Principal Investigator

Francesco Giammarile, MD, PhD

STUDY_DIRECTOR

International Atomic Energy Agency

Study Locations (Sites)

Massachusetts General Hospital, Havard Medical School

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: International Atomic Energy Agency

Francesco Giammarile, MD, PhD, STUDY_DIRECTOR, International Atomic Energy Agency

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01

Study Completion Date2026-07-01

Study Record Updates

Study Start Date2021-12-01

Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

History of Myocardial Infarction