Screening for Coronary Artery Disease After Mediastinal Irradiation

Not Applicable

Completed

• Conditions: Radiation Therapy; Coronary Artery Disease; Hodgkin Lymphoma

• Registration Number: NCT01271127
• Lead Sponsor: Leiden University Medical Center

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.

Detailed 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)

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands