Screening for Coronary Artery Disease After Mediastinal Irradiation (SCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01271127
Recruitment Status : Completed
First Posted : January 6, 2011
Last Update Posted : June 12, 2013
Information provided by (Responsible Party):
L.A.Daniels, 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.

Condition or disease Intervention/treatment Phase
Radiation Therapy Coronary Artery Disease Hodgkin Lymphoma Radiation: CT coronary angiography Not Applicable

Detailed Description:


  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


CT-coronary angiography and calcium score, to be performed as a screening method (to indicate further diagnostic treatent procedures)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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 : January 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Intervention Details:
    Radiation: CT coronary angiography
    patient will undergo one CT coronary angiography

Primary Outcome Measures :
  1. accurately identifying asymptomatic coronary artery disease [ Time Frame: 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 :
  1. prevalnce of cornary artery disease and frequency/type of subsequent intervention [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01271127

Leiden University Medical Center
Leiden, Zuid-Holland, Netherlands, 2300WB
Sponsors and Collaborators
Leiden University Medical Center
Principal Investigator: A.D.G. KRol, MD, PhD Leiden University Medical Centre

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: L.A.Daniels, MD, Leiden University Medical Center Identifier: NCT01271127     History of Changes
Other Study ID Numbers: NL31278.058.10
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by L.A.Daniels, Leiden University Medical Center:
radiation therapy
coronary artery disease
Hodgkin Lymphoma

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases