Screening for Coronary Artery Disease After Mediastinal Irradiation

Leiden University Medical Center50 enrolled

Overview

Survivors of Hodgkin 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 symptomatic individuals. In the trial the efficacy and therapeutic consequences of screening for coronary artery diasease by multi-slice CT (MSCT) among asymptomatic HL survivors will be evaluated.

Objectives: 1. to determine whether MSCT as a screening method of HL survivors treated with mediastinal irradiation accurately identifies asymptomatic significant coronary artery disease. 2. to establish the prevelance of coronary abnormalities in HL survivors treated with mediastinal irradiation 3. to determine the frequency and type of intervention 4. to evaluate the acceptance of screening and asses quality of life among Hl survivors. Study polulation: 50 long term survivors of HL, previously treatef with mediastinal irradiation without present evidence of cardiovascular disease Intervention: CT-coronary angiography and calcium score, to be performed as a screening method (to indicate further diagnostic treatent procedures)

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Radiation Therapy

Eligibility

Sex: ALLMin age: 35 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * history of Hodgkin Lymphoma(all stages) with at least 10 disease free survival * current age between 35-60 * mediastinal irradiation as part of HL treatment, radiotherapy data available * written informed consent Exclusion Criteria: * current treatment for cardiovascualr disease, excelt hypertension hypercholesterolemia or cardiac murmurs * known or sypmtomatic heart failure * impaired kidney function (Cockcroft \< 55 ml/min) * known contrast allergy * invasive angiography in past 2 years * presence of life threatening disorder

Outcomes

Primary Outcomes

accurately identifying asymptomatic coronary artery disease

to determine whether Ct coronary angiography as a screening method acuurately identifies asymptomatic coronary artery disease in a high risk poulation (HL survivors after mediastinal irradiation)

Time frame: one year

Secondary Outcomes

prevalnce of cornary artery disease and frequency/type of subsequent intervention

to establish the prevelence of coronary abnormalities in HL survivors treated with mediastinal irradiation, and to determine the frequency and type of subsequent interventions