Identifying cardiovascular risk using FDG PET imaging in patients with a history of heart attack

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

This study is testing if special imaging can help identify heart attack survivors who are at risk for future heart problems.

Quick facts

• Study type: Observational
• Enrollment: 2041 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: International Atomic Energy Agency (Government)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05138718 on ClinicalTrials.gov

What this trial studies

This observational trial aims to establish reliable FDG PET imaging thresholds to identify patients at risk for cardiovascular events following a myocardial infarction. Participants aged 18-80 with a documented heart attack more than 90 days prior will undergo non-enhanced whole-body FDG PET/CT scans to quantify arterial FDG uptake in key areas such as the carotid arteries and aorta. Additionally, blood and genetic biomarkers linked to atherosclerosis will be analyzed to enhance risk prediction. The study will also include a 4-year follow-up to assess the occurrence of cardiovascular events.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-80 with a documented myocardial infarction occurring more than 90 days prior and who are clinically stable.

Not a fit: Patients with severe congestive heart failure or those with active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk stratification and personalized treatment strategies for patients with a history of myocardial infarction.

How similar studies have performed: Previous studies have indicated that FDG PET imaging may provide superior risk stratification compared to traditional blood biomarkers, suggesting potential success for this approach.

Eligibility criteria

Inclusion 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)

Exclusion Criteria:

* 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 this trial is running

Boston, Massachusetts

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

Study contacts

• Study coordinator: Francesco Giammarile, MD, PhD

Conditions History of Myocardial Infarction