- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01271127
Screening for Coronary Artery Disease After Mediastinal Irradiation (SCAR)
June 11, 2013 updated by: L.A.Daniels, Leiden University Medical Center
Screening for Coronary Artery Disease After Mediastinal Irradiation in Hodgkin Lymphoma Survivors
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.
Study Overview
Status
Completed
Intervention / Treatment
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)
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zuid-Holland
-
Leiden, Zuid-Holland, Netherlands, 2300WB
- Leiden University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: A.D.G. KRol, MD, PhD, Leiden University Medical Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
January 5, 2011
First Submitted That Met QC Criteria
January 5, 2011
First Posted (Estimate)
January 6, 2011
Study Record Updates
Last Update Posted (Estimate)
June 12, 2013
Last Update Submitted That Met QC Criteria
June 11, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Lymphoma
- Hodgkin Disease
Other Study ID Numbers
- NL31278.058.10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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