A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer (ABCART)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Winthrop University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Winthrop University Hospital
Information provided by (Responsible Party):
Alexander Hindenburg, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00960401
First received: August 13, 2009
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to compare plaque burden in the coronary and carotid arteries 5 years after adjuvant radiotherapy in women with right sided breast cancer vs left sided breast cancer.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Pilot Study "A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer"

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • to compare plaque burden in the coronary and carotid arteries after radiotherapy for breast cancer [ Time Frame: after 5 years of radiotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: August 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
cardiac counseling
10 left sided breast cancer patients 10 right sided breast cancer patients
coronary artery evaluation
10 left sided breast cancer 10 right sided breast cancer

Detailed Description:

This study reviews case series of patients with a history of breast cancer treated with radiotherapy for at least five years. The study measures atherosclerosis by using coronary and carotid artery calcium scoring.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

breast cancer patients after radiation treatment

Criteria

Inclusion Criteria:

  • women dx with ductal carcinoma in situ or breast cancer, stage 0 to stage IIIc, who received conservative surgery and radiotherapy at least 5 years ago
  • less than or equal to age 60

Exclusion Criteria:

  • hx of coronary disease prior to tx of ductal carcinoma in situ or breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960401

Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Alexander Hindenburg, MD
Winthrop University Hospital
Investigators
Principal Investigator: Alexander Hindenburg, MD Winthrop University Hospital
  More Information

No publications provided

Responsible Party: Alexander Hindenburg, MD, Principal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00960401     History of Changes
Other Study ID Numbers: 05018
Study First Received: August 13, 2009
Last Updated: August 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
coronary calcium scoring
breast cancer patients
radiation treatment

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Breast Neoplasms
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014