Screening for Coronary Artery Disease After Mediastinal Irradiation (SCAR)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Leiden University Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Leiden University Medical Center
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01271127
First received: January 5, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Further study details as provided by Leiden University Medical Center:
Primary Outcome Measures:
- accurately identifying asymptomatic coronary artery disease [ Time Frame: one year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]to establish the prevelence of coronary abnormalities in HL survivors treated with mediastinal irradiation, and to determine the frequency and type of subsequent interventions
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Radiation: CT coronary angiography
patient will undergo one CT coronary angiography
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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271127
Contacts
| Contact: A.D.G Krol, MD, PhD | 0031715263486 | |
| Contact: L A Daniels, MD | 0031715263486 | l.a.daniels@lumc.nl |
Locations
| Netherlands | |
| Leiden University Medical Center | Recruiting |
| 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
No publications provided
| Responsible Party: | A.D.G Krol, MD, PhD, Leids Universitair Medisch Centrum |
| ClinicalTrials.gov Identifier: | NCT01271127 History of Changes |
| Other Study ID Numbers: | NL31278.058.10 |
| Study First Received: | January 5, 2011 |
| Last Updated: | January 5, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Leiden University Medical Center:
|
radiation therapy coronary artery disease Hodgkin Lymphoma |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Hodgkin Disease Lymphoma Heart Diseases Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013