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

This study is ongoing, but not recruiting participants.
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
History of Changes
  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:

U.S. FDA Resources

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
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
Breast Neoplasms
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013