Radiation TherapySCARNCT01271127
Screening for Coronary Artery Disease After Mediastinal Irradiation
A study testing CT coronary angiography in people with Radiation Therapy and Coronary Artery Disease, run by Leiden University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Radiation Therapy, Coronary Artery Disease, Hodgkin Lymphoma
- What is being tested?
- CT coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2300WB
About this study
Official title: 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.
Read the 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)
- Conditions
- Radiation Therapy, Coronary Artery Disease, Hodgkin Lymphoma
- Being tested
- CT coronary angiography
- Keywords
- radiation therapy, coronary artery disease, Hodgkin Lymphoma
- Medical subject headings
- Coronary Artery Disease, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT coronary angiographyRadiation
patient will undergo one CT coronary angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L.A.Daniels, Leiden University Medical Center
- Investigators
- A.D.G. KRol, MD, PhD, Principal investigator, Leiden University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271127
- Sponsor's protocol ID
- NL31278.058.10
- Acronym
- SCAR
- Status last verified
- Jun 2013
- First submitted
- 5 Jan 2011
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25195991Daniels 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.
PubMed 24692582
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Coronary Artery Disease After Mediastinal Irradiation in Hodgkin Lymphoma Survivors
- ClinicalTrials.gov ID
- NCT01271127
- Acronym / sponsor ID
- SCAR / NL31278.058.10
- Conditions
- Radiation Therapy, Coronary Artery Disease, Hodgkin Lymphoma
- Keywords
- radiation therapy, coronary artery disease, Hodgkin Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT coronary angiographypatient will undergo one CT coronary angiography | Radiation | – |
Primary outcome
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)
1 secondary outcome
prevalnce of cornary artery disease and frequency/type of subsequent intervention
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Derived from this study: PubMed 25195991Daniels 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.
- Derived from this study: PubMed 24692582Daniels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.D.G. KRol, MD, PhD principal investigator
Leiden University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT coronary angiography in people with Radiation Therapy and Coronary Artery Disease, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accurately identifying asymptomatic coronary artery disease (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271127, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.