SCAR: Screening for Coronary Artery Disease After Mediastinal Irradiation

Sponsor

Leiden University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01271127

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Therapy Coronary Artery Disease Hodgkin Lymphoma	Radiation: CT coronary angiography	N/A

Detailed Description

Objectives:

to determine whether MSCT as a screening method of HL survivors treated with mediastinal irradiation accurately identifies asymptomatic significant coronary artery disease.
to establish the prevelance of coronary abnormalities in HL survivors treated with mediastinal irradiation
to determine the frequency and type of intervention
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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Screening for Coronary Artery Disease After Mediastinal Irradiation in Hodgkin Lymphoma Survivors

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Outcome Measures

Primary Outcome Measures

accurately identifying asymptomatic coronary artery disease [one year]
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)

Secondary Outcome Measures

prevalnce of cornary artery disease and frequency/type of subsequent intervention [one year]
to establish the prevelence of coronary abnormalities in HL survivors treated with mediastinal irradiation, and to determine the frequency and type of subsequent interventions

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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