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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

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 468 studies in Atherosclerosis with a site in United States — 47 open to participants now, 75 under way, 17 of them phase 3. Atherosclerosis · United States.

Enrollment
120th of 137
20 · median 170
Started
2005
with 14 others
Observational
137 of 468
9 open now
Registered
179th of 468
by date

Among the 468 studies in Atherosclerosis with a site in United States, this one is the 120th largest by enrollment of the 137 observational ones that give a count, is one of 15 that started in 2005, is one of 137 observational ones, and was the 179th registered.

Atherosclerosis

1,518 studies on the registry are indexed under Atherosclerosis; 225 are open to participants now.

Browse Atherosclerosis studies →

Open to participants now

47 of the 468 studies in Atherosclerosis with a site in United States are open now. Recruiting first, the newest first:

42 more — sign in →

All 47 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 161 Atherosclerosis studies recruiting now, 84 (52%) set no upper age limit and 33 (20%) stop at 75 or younger; 16 take children under 18; 33 take healthy volunteers.

This study: 18 Years to 60 Years · female · healthy volunteers too.

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02

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.

03

Conditions studied

  • Atherosclerosis

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Keywords

  • coronary calcium scoring
  • breast cancer patients
  • radiation treatment
04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

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
08

Study locations

1 site
  • Winthrop University Hospital
    Mineola, New York 11501, United States
09

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2005, a primary completion of May 2007 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Nov 2023, 16 years 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2009
First posted
Aug 17, 2009
Start
Aug 2005
Primary completionActual
May 2007
CompletionActual
Jan 2014
Results first posted
Nov 27, 2023
Last update
Nov 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

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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Discussion

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