Coronary Artery DiseaseBBCNCT03235622
Women Health Cohort for Breast, Bone and Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Seoul National University Hospital.
Trial summary
A single center cohort which enrolled women who performed mammography, bone densitometry (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March 2011 to February 2013. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary CT angiography
- How many people
- 2,100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: * The number of women who met inclusion criteria was 2113. * 13 women were excluded due to history of coronary revascularization (n=1) and breast surgery or intervention (n=12). * Finally, 2100 women were enrolled to the BBC cohort.
Who may be able to join
- Women (≥ 40 years) who performed mammography, bone DEXA, and coronary CT angiography at health promotion center of Seoul National University Bundang Hospital.
Who cannot join
- Women who have history of breast surgery or intervention
- Women who have history of myocardial infarction or revascularization
- Too poor image quality of coronary CT angiography for interpretation
- Renal dysfunction with serum creatinine ≥ 1.4mg/dL
About this study
A single center cohort which enrolled women who performed mammography, bone densitometry (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March 2011 to February 2013.
Read the detailed description
To evaluate whether bone mineral density and breast arterial calcification can predict coronary artery disease in women older than 40 years
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary CT angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT angiographyDiagnostic test
Also called Bone DEXA, Mammography
Presence of coronary plaques Characteristic of coronary plaques
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of coronary plaque
Any coronary plaque in coronary CT angiography
Measured: 5 years
Secondary outcomes (2)
Characteristics of coronary plaque
Plaque characteristics (fibrosis, calcification, lipid, thrombosis) in coronary CT angiography
Measured: 5 years
Major adverse cardiovascular events
Cardiac death, nonfatal myocardial infarction, ischemic stroke, coronary revascularization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study startMar 2011
- Primary completionFeb 2013
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Won Suh, Seoul National University Hospital
- Investigators
- Jung-Won Suh, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235622
- Sponsor's protocol ID
- B-1707-406-102
- Acronym
- BBC
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yoon YE, Kim KM, Han JS, Kang SH, Chun EJ, Ahn S, Kim SM, Choi SI, Yun B, Suh JW. Prediction of Subclinical Coronary Artery Disease With Breast Arterial Calcification and Low Bone Mass in Asymptomatic Women: Registry for the Women Health Cohort for the BBC Study. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1202-1211. doi: 10.1016/j.jcmg.2018.07.004. Epub 2018 Aug 15.
PubMed 30121271
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women Health Cohort for Breast, Bone and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03235622
- Acronym / sponsor ID
- BBC / B-1707-406-102
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single center cohort which enrolled women who performed mammography, bone densitometry (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March 2011 to February 2013.
Detailed description
To evaluate whether bone mineral density and breast arterial calcification can predict coronary artery disease in women older than 40 years
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * The number of women who met inclusion criteria was 2113. * 13 women were excluded due to history of coronary revascularization (n=1) and breast surgery or intervention (n=12). * Finally, 2100 women were enrolled to the BBC cohort.
Key inclusion criteria (1 listed)
- Women (≥ 40 years) who performed mammography, bone DEXA, and coronary CT angiography at health promotion center of Seoul National University Bundang Hospital.
Key exclusion criteria (4 listed)
- Women who have history of breast surgery or intervention
- Women who have history of myocardial infarction or revascularization
- Too poor image quality of coronary CT angiography for interpretation
- Renal dysfunction with serum creatinine ≥ 1.4mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary CT angiographyAlso: Bone DEXA, MammographyPresence of coronary plaques Characteristic of coronary plaques | Diagnostic test | – |
Primary outcome
Presence of coronary plaque
Time frame: 5 years
Any coronary plaque in coronary CT angiography
2 secondary outcomes
Characteristics of coronary plaque
Time frame: 5 years
Major adverse cardiovascular events
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 30121271Yoon YE, Kim KM, Han JS, Kang SH, Chun EJ, Ahn S, Kim SM, Choi SI, Yun B, Suh JW. Prediction of Subclinical Coronary Artery Disease With Breast Arterial Calcification and Low Bone Mass in Asymptomatic Women: Registry for the Women Health Cohort for the BBC Study. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1202-1211. doi: 10.1016/j.jcmg.2018.07.004. Epub 2018 Aug 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Won Suh, MD, PhD principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of coronary plaque (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.