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Screening for Coronary Artery Disease After Mediastinal Irradiation (SCAR)

Primary Purpose

Radiation Therapy, Coronary Artery Disease, Hodgkin Lymphoma

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CT coronary angiography
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Radiation Therapy focused on measuring radiation therapy, coronary artery disease, Hodgkin Lymphoma

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leiden University Medical Center

Outcomes

Primary Outcome Measures

accurately identifying asymptomatic coronary artery disease
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
to establish the prevelence of coronary abnormalities in HL survivors treated with mediastinal irradiation, and to determine the frequency and type of subsequent interventions

Full Information

First Posted
January 5, 2011
Last Updated
June 11, 2013
Sponsor
Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01271127
Brief Title
Screening for Coronary Artery Disease After Mediastinal Irradiation
Acronym
SCAR
Official Title
Screening for Coronary Artery Disease After Mediastinal Irradiation in Hodgkin Lymphoma Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Therapy, Coronary Artery Disease, Hodgkin Lymphoma
Keywords
radiation therapy, coronary artery disease, Hodgkin Lymphoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
CT coronary angiography
Intervention Description
patient will undergo one CT coronary angiography
Primary Outcome Measure Information:
Title
accurately identifying asymptomatic coronary artery disease
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)
Time Frame
one year
Secondary Outcome Measure Information:
Title
prevalnce of cornary artery disease and frequency/type of subsequent intervention
Description
to establish the prevelence of coronary abnormalities in HL survivors treated with mediastinal irradiation, and to determine the frequency and type of subsequent interventions
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.D.G. KRol, MD, PhD
Organizational Affiliation
Leiden University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2300WB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25195991
Citation
Daniels LA, Krol SD, de Graaf MA, Scholte AJ, van 't Veer MB, Putter H, de Roos A, Schalij MJ, van de Poll-Franse LV, Creutzberg CL. Impact of cardiovascular counseling and screening in Hodgkin lymphoma survivors. Int J Radiat Oncol Biol Phys. 2014 Sep 1;90(1):164-71. doi: 10.1016/j.ijrobp.2014.05.038.
Results Reference
derived
PubMed Identifier
24692582
Citation
Daniels LA, Krol AD, de Graaf MA, Scholte AJ, Van't Veer MB, Putter H, de Roos A, Schalij MJ, Creutzberg CL. Screening for coronary artery disease after mediastinal irradiation in Hodgkin lymphoma survivors: phase II study of indication and acceptancedagger. Ann Oncol. 2014 Jun;25(6):1198-203. doi: 10.1093/annonc/mdu130. Epub 2014 Mar 31.
Results Reference
derived

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Screening for Coronary Artery Disease After Mediastinal Irradiation

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