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CompletedNCT00960401ABCARTUpdated Nov 27, 2023Results posted

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

An observational study in Atherosclerosis, sponsored by Winthrop University Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by Winthrop University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
20
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Atherosclerosis

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Keywords

  • coronary calcium scoring
  • breast cancer patients
  • radiation treatment
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

breast cancer patients after radiation treatment

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

Exclusion Criteria:

  • hx of coronary disease prior to tx of ductal carcinoma in situ or breast cancer
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
20 participants (actual)

Groups and 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

05

What researchers measure

Primary outcomes

  1. Number of Participants Analyzed for Coronary Calcium Burden by AGS

    Number of participants who received a coronary calcium scan.

    Time frame: Year 5 Post-Initiation of Radiotherapy

06

Results

Posted Nov 27, 2023

Participant flow

Participant flow — Overall Study
MilestoneCoronary Artery Evaluation Left Side Breast CancerCoronary Artery Evaluation Right Side Breast Cancer
Started911
Completed911
Not completed00

Outcome measures

PrimaryNumber of Participants Analyzed for Coronary Calcium Burden by AGS

Number of participants who received a coronary calcium scan.

Time frame:
Year 5 Post-Initiation of Radiotherapy
Reported as:
Count of participants · Participants
Number of Participants Analyzed for Coronary Calcium Burden by AGS
ParticipantsCoronary Artery Evaluation Left Side Breast CancerCoronary Artery Evaluation Right Side Breast Cancer
Number of Participants Analyzed for Coronary Calcium Burden by AGS911

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Coronary Artery Evaluation—0/20 (0%)0/20 (0%)

Baseline characteristics

Age 60 years or younger at time of radiatiion to chest wall. All subjects had radiation at least 5 years prior to enrollment. Patients with clinical symtoms of CAD were excluded.

Age, Categorical
Age, Categorical(Participants)Coronary Artery Evaluation Left Side Breast CancerCoronary Artery Evaluation Right Side Breast CancerTotal
<=18 years000
Between 18 and 65 years91120
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Coronary Artery Evaluation Left Side Breast CancerCoronary Artery Evaluation Right Side Breast CancerTotal
Female91120
Male000
07

Study locations

1 site
  • Winthrop University Hospital
    Mineola, New York 11501, United States
08

References and documents

Publications

  • Chang M, Suh J, Kirtani V, Dobrescu A, Haas J, Zeldis S, Shayani S, Hindenburg AA. Coronary Calcium Scanning in Patients after Adjuvant Radiation for Early Breast Cancer and Ductal Carcinoma In situ. Front Oncol. 2013 Sep 25;3:253. doi: 10.3389/fonc.2013.00253. eCollection 2013. PubMed 24093087 ↗
09

Registry details

Key details

Study ID
NCT00960401
Lead sponsor
Winthrop University Hospital
Responsible party
Sponsor
First posted
Aug 17, 2009
Start date
Aug 2005
Primary completion
May 2007
Completion
Jan 2014
Results posted
Nov 27, 2023
Last update
Nov 27, 2023

Study contacts

Alexander Hindenburg, MD
principal investigator · Winthrop University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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