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Completed

NCT Number: NCT01271127

Screening for Coronary Artery Disease After Mediastinal Irradiation

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.

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Key information

Conditions

Radiation Therapy Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myocardial Ischemia Neoplasms Neoplasms by Histologic Type Vascular Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, South Holland, 2300WB, Netherlands

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT coronary angiography

Radiation

patient will undergo one CT coronary angiography

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Acronym: SCAR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2011
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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