Screening for Coronary Artery Disease After Mediastinal Irradiation (SCAR)

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Radiation Therapy; Hodgkin Lymphoma; Coronary Artery Disease

Treatments: Radiation: CT coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT01271127

NL31278.058.10

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 50 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)