screening for coronary disease after mediastinal irradiation in Hodgkin Lymphoma survivors

Survivors of Hodgkin*s lymphoma (HL) are known to have an increased risk of
developing late treatment sequelae such as cardiovascular events due to
coronary artery disease. At present no active screening is performed in these
patients, since it is not known whether screening and subsequent treatment by
means of revascularization is effective in reducing the risk of cardiovascular
events in asymptomatic individuals.
In this phase II trial the efficacy and therapeutic consequences of screening
for coronary artery disease by multi-slice CT (MSCT) among asymptomatic HL
survivors will be evaluated

Primary objectives:
1: To determine whether CT- coronary angiography by MSCT as a screening method
of HL survivors treated with mediastinal irradiation accurately identifies
asymptomatic significant coronary artery disease.
2: To establish the prevalence of coronary abnormalities in HL survivors
treated with mediastinal irradiation.

Secondary objectives:
1: To determine the frequency and type of subsequent interventions
2: To determine the total costs of screening and subsequent intervention in
this cohort.
3: To evaluate the acceptance of cardiac screening and to assess quality of
life among HL survivors by means of validated questionnaires.

Eligible patients from our present follow-up population of HL survivors will be
invited by mail for a following visit in the so called late-effects screening
pathway of the outpatient clinic of the LUMC Department of Radiotherapy.
In this visit the pilot study will be introduced, oral and written information
will be given and an informed consent form will be handed out. Eligible
patients will also be asked to participate in a study of quality of life and
acceptance of screening by means of completing validated questionairres
(EORTC-QLQ-C30, FAS and INFO 25) before and after the cardiac screening.
Participation in the quality of life part of this study is not mandatory for
participation in the cardiac screening part of this study.
After consent for the cardiac screening has been obtained, patients will be
referred to the LUMC Department of Cardiology (Prof. Dr. M. Schalij) for the
standard cardiac screening which is part of the late effects screening care
pathway. This will take place in one visit and will consist of a specific
patient history and physical examination, fractionated serum cholesterol and
glucose testing, a resting ECG, and (stress) echocardiogram.
In a separate visit contrast enhanced CT- coronary angiography will be
performed at the Department of Radiology, according to the current existing
LUMC radiology protocols. If significant coronary disease, defined as >= 50%
stenosis of diameter of the lumen of the large coronary arteries is found,
revascularization of the narrowed lumen by means of percutaneous coronary
intervention (PCI) is considered indicated in compliance with existing LUMC
cardiology protocols, and this will be discussed with the patient in a
subsequent visit to the Cardiology Outpatient Department.


Intervention:
CT coronary-angiography, to be performed as a screening method (to indicate
further diagnostic treatment procedures).

Burden: - at least three visits to the radiation onclogy and cardiology out
patient clinic. If intervention is needed, more visits (depending ionthe nature
of intervention) will follow.

Risks: minimal risks of contrast allergy