Clinical trial NCT01271127: Screening for Coronary Artery Disease After Mediastinal Irradiation
Official title: Screening for Coronary Artery Disease After Mediastinal Irradiation in Hodgkin Lymphoma Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Therapy
Coronary Artery Disease
Hodgkin Lymphoma
Keywords: radiation therapy
coronary artery disease
Hodgkin Lymphoma
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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:

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 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

Primary outcomes:
measure: accurately identifying asymptomatic coronary artery disease
timeFrame: one year
Secondary outcomes:
measure: prevalnce of cornary artery disease and frequency/type of subsequent intervention
timeFrame: one year
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Centre
name: A.D.G. KRol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.