NCT00388713

Brief Summary

Radiation induced accelerated atherosclerosis is a well known entity that occurs in different regions, according to the therapy delivered.It is usually begins to be clinically evident several years after the radiation incident, as there is sufficient functional reserve to these vessels.Our proposal is aimed to better characterize this side effect. For that purpose, we have chosen to study women who received radiation to the breast, in which part of the carotid in the irradiated side was in the high energy radiation field. We will use Intima Media Thickening ultrasound to study the pattern of atherosclerosis plaque formation in radiated carotid arteries as compared to non-irradiated carotid arteries in women who are receiving radiation therapy for breast cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 16, 2007

Status Verified

December 1, 2005

First QC Date

October 15, 2006

Last Update Submit

May 15, 2007

Conditions

Keywords

Radiation therapyRadiation-Induced AtherosclerosisCarotid Artery DiseasesBreast CancerIntima Media thickening Ultrasound

Interventions

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women 18-85 Y.O.
  • received or about to receive unilateral breast and supraclavicular radiation therapy
  • No evidence of disease

You may not qualify if:

  • prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Related Publications (3)

  • Adams MJ, Hardenbergh PH, Constine LS, Lipshultz SE. Radiation-associated cardiovascular disease. Crit Rev Oncol Hematol. 2003 Jan;45(1):55-75. doi: 10.1016/s1040-8428(01)00227-x.

    PMID: 12482572BACKGROUND
  • Cheng SW, Ting AC, Lam LK, Wei WI. Carotid stenosis after radiotherapy for nasopharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2000 Apr;126(4):517-21. doi: 10.1001/archotol.126.4.517.

    PMID: 10772307BACKGROUND
  • Dorresteijn LD, Kappelle AC, Boogerd W, Klokman WJ, Balm AJ, Keus RB, van Leeuwen FE, Bartelink H. Increased risk of ischemic stroke after radiotherapy on the neck in patients younger than 60 years. J Clin Oncol. 2002 Jan 1;20(1):282-8. doi: 10.1200/JCO.2002.20.1.282.

    PMID: 11773180BACKGROUND

MeSH Terms

Conditions

Abnormalities, Radiation-InducedAtherosclerosisBreast NeoplasmsCarotid Artery Diseases

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRadiation InjuriesWounds and InjuriesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Amichay Meirovitz, MD

    Hadassah University Hospital, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2006

First Posted

October 17, 2006

Study Start

October 1, 2006

Study Completion

January 1, 2010

Last Updated

May 16, 2007

Record last verified: 2005-12

Locations