The HARMONIC project: Study design for assessment of cancer risks following cardiac fluoroscopy in childhood

Abstract

The HARMONIC project (Health Effects of Cardiac Fluoroscopy and Modern Radiotherapy in Paediatrics) is a European study aiming to improve our understanding of the long-term health risks from radiation exposures in childhood and early adulthood. Here, we present the study design for the cardiac fluoroscopy component of HARMONIC. A pooled cohort of approximately 100 000 patients who underwent cardiac fluoroscopy procedures in Belgium,

Congenital Heart Disease and the Risk of Cancer: An Update on the Genetic Etiology, Radiation Exposure Damage, and Future Research Strategies

“…Finally, epidemiological studies should be integrated with research with longitudinal measurements of biomarkers of risk and susceptibility in large cohorts of patients with long-term prospective follow-up [ 43 ]. These new studies will generate the evidence needed to optimize treatment in CHD patients and develop better radiation protection to reduce cancer and late radiation-induced toxicities.…”

“…In the future, the ongoing large-cohort HARMONIC study involving a combined cohort size ten times larger than any previous epidemiological analysis should contribute to improving our understanding of the potential long-term cancer risks in CHD children [ 43 ].…”

“…The HARMONIC study is also bridged by a biological component, which will investigate biomarkers of radiation exposure and predictors of adverse effects as a complementary strategy to the traditional analytical epidemiology [ 43 ].…”

Stress Echo 2030: The Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging

“…Left ventricular function will also be assessed through measurement of ejection fraction, wall motion score index and E/e' at baseline and peak stress. At the moment of testing, also data on medical radiation exposure will be systematically collected with the generation of a simple radiological risk score as detailed in project 6, with specific values of effective dose available for pediatric exposures associated with higher biological effects for any given physical dose exposure [85].…”

“…Pediatric SE is increasingly used in children and adults for the detection of myocardial ischemia (see project 1) and for functional characterization and risk stratification of grown-up patients with congenital heart disease [84]. The lack of radiation exposure is especially important in these patients who already receive an intensive radiation exposure with associated increased risk of cancer [85]. Tetralogy of Fallot is the most common cyanotic congenital heart lesion, and since treatments became available over 70 years ago, there are now a large number of patients with repaired Tetralogy of Fallot.…”