NCT01271127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

2.4 years

First QC Date

January 5, 2011

Last Update Submit

June 11, 2013

Conditions

Radiation TherapyCoronary Artery DiseaseHodgkin Lymphoma

Keywords

radiation therapycoronary artery diseaseHodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • prevalnce of cornary artery disease and frequency/type of subsequent intervention

    one year

Interventions

CT coronary angiographyRADIATION

patient will undergo one CT coronary angiography

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2300WB, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 25195991DERIVED

  • 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.

    PMID: 24692582DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseHodgkin Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • A.D.G. KRol, MD, PhD

    Leiden University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations

NL(1)