Screening for Coronary Artery Disease After Mediastinal Irradiation - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease Hodgkin Disease Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma

U.S. FDA Resources

Further study details as provided by L.A.Daniels, Leiden University Medical Center:

Primary Outcome Measures:

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:

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


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:

patient will undergo one CT coronary angiography

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)

Eligibility


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Daniëls 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.

Daniëls 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 acceptance†. Ann Oncol. 2014 Jun;25(6):1198-203. doi: 10.1093/annonc/mdu130. Epub 2014 Mar 31.


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

Keywords provided by L.A.Daniels, Leiden University Medical Center:


radiation therapy coronary artery disease Hodgkin Lymphoma

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on June 22, 2017

Screening for Coronary Artery Disease After Mediastinal Irradiation (SCAR)