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Screening for Coronary Artery Disease After Mediastinal Irradiation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01271127
Acronym
SCAR
Enrollment
50
Registered
2011-01-06
Start date
2011-01-31
Completion date
2013-06-30
Last updated
2013-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Therapy, Coronary Artery Disease, Hodgkin Lymphoma

Keywords

radiation therapy, coronary artery disease, Hodgkin Lymphoma

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)

Interventions

patient will undergo one CT coronary angiography

Sponsors

Leiden University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
accurately identifying asymptomatic coronary artery diseaseone yearto 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

MeasureTime frameDescription
prevalnce of cornary artery disease and frequency/type of subsequent interventionone yearto establish the prevelence of coronary abnormalities in HL survivors treated with mediastinal irradiation, and to determine the frequency and type of subsequent interventions

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026