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


N/A
35 Years
60 Years
Not Enrolling
Both
Radiation Therapy, Coronary Artery Disease, Hodgkin Lymphoma

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Trial Information

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


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)


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

accurately identifying asymptomatic coronary artery disease

Outcome Description:

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)

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

A.D.G. KRol, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Leiden University Medical Centre

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

NL31278.058.10

NCT ID:

NCT01271127

Start Date:

January 2011

Completion Date:

June 2013

Related Keywords:

  • Radiation Therapy
  • Coronary Artery Disease
  • Hodgkin Lymphoma
  • radiation therapy
  • coronary artery disease
  • Hodgkin Lymphoma
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Hodgkin Disease
  • Lymphoma

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