Screening for Coronary Artery Disease After Mediastinal Irradiation

Coronary Artery Disease Clinical Trial

— SCAR  

Official title:

Screening for Coronary Artery Disease After Mediastinal Irradiation in Hodgkin Lymphoma Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271127
• Other study ID #: NL31278.058.10
• Status: Completed
• Phase: N/A
• First received: January 5, 2011
• Last updated: June 11, 2013
• Start date: January 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hodgkin Disease
• Hodgkin Lymphoma
• Myocardial Ischemia
• Radiation Therapy

Intervention

Radiation:
• CT coronary angiography
patient will undergo one CT coronary angiography

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	one year	No
Secondary	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	one year	No