Screening for Coronary Artery Disease After Mediastinal Irradiation (SCAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
L.A.Daniels, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01271127
First received: January 5, 2011
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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 Intervention
Radiation Therapy
Coronary Artery Disease
Hodgkin Lymphoma
Radiation: CT coronary angiography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Screening for Coronary Artery Disease After Mediastinal Irradiation in Hodgkin Lymphoma Survivors

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • accurately identifying asymptomatic coronary artery disease [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • prevalnce of cornary artery disease and frequency/type of subsequent intervention [ Time Frame: one year ] [ Designated as safety issue: No ]
    to establish the prevelence of coronary abnormalities in HL survivors treated with mediastinal irradiation, and to determine the frequency and type of subsequent interventions


Enrollment: 50
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: CT coronary angiography
    patient will undergo one CT coronary angiography
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)

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271127

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

No publications provided

Responsible Party: L.A.Daniels, MD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01271127     History of Changes
Other Study ID Numbers: NL31278.058.10
Study First Received: January 5, 2011
Last Updated: June 11, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Leiden University Medical Center:
radiation therapy
coronary artery disease
Hodgkin Lymphoma

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

ClinicalTrials.gov processed this record on July 20, 2014