Recruiting

FDG & Myocardial Infarction

Sponsor:

International Atomic Energy Agency

Code:

NCT05138718

Conditions

History of Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

18F-FDG PET/CT

Study Details

Brief 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.

Conditions

History of Myocardial Infarction

Study ID

NCT05138718

Start date

Dec 1, 2021

Status verified date

Nov, 2021

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2041 participants

Anticipated

Interventions and Outcome Measures

Interventions

18F-FDG PET/CT

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Francesco Giammarile, MD, PhD

+436606820396f.giammarile@iaea.org

Diana Paez, MD

+4316521670d.paez@iaea.org

Locations

Massachusetts General Hospital, Havard Medical School

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ahmed Tawakol, MD, PhD

atawakol@mgh.harvard.edu

More Information

Sponsor

International Atomic Energy Agency

Last update posted

Dec 1, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by International Atomic Energy Agency on 2021-12-01.