Cardiovascular Health Risk CommunicationNCT07809932
Breast Artery Calcification (BAC) and Female Cardiovascular Disease
An observational study of Cardiovascular Health Risk Communication and Cardiovascular (CV) Risk, run by Northwell Health at 1 site in United States.
Trial summary
The investigators are recruiting women with and without Breast Artery Calcification (BAC) on their mammograms. Each participant in the study will undergo bloodwork at a Northwell Health lab, a cardiac CT scan, and fill out some brief questionnaires. Results will be shared with the respective participant. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health Risk Communication, Cardiovascular (CV) Risk, Cardiovascular Disease Prevention
- What is being tested?
- Cardiac CT Scan and Bloodwork
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential subjects will be recruited from all women who underwent a mammogram at Northwell Health.
Who may be able to join
- female
- 55-65 years old
Who cannot join
- ischemia
- diabetes
- statin or cholesterol lowering medicine use
- cardiovascular disease: coronary artery disease, heart failure, arrhythmia, significant valvular disease
- history of breast surgery or breast cancer
- pregnant women
- breastfeeding women
- women unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
About this study
Official title: Risk Stratification for Asymptomatic Women With Incidentally Found Breast Artery Calcification on Their Routine Screening Mammogram
The investigators are recruiting women with and without Breast Artery Calcification (BAC) on their mammograms. Each participant in the study will undergo bloodwork at a Northwell Health lab, a cardiac CT scan, and fill out some brief questionnaires. Results will be shared with the respective participant. At the conclusion of the study, statistical analyses will be performed to further understand the associations between BAC and cardiovascular markers.
Read the detailed description
Previous work has demonstrated an association between incidentally found BAC on screening mammograms and long-term major adverse cardiovascular events. However, there are no guidelines for how to manage asymptomatic women with no history of cardiovascular disease who have incidentally found BAC on a screening mammogram. This study will simulate a reasonable approach that a cardiologist might take in determining how to manage such patients. The study is unique compared with prior studies that have utilized a convenience sample, the investigators seek to gather this information in two parallel cohorts prospectively.
The investigators seek to recruit 100 women with BAC = 0 and 100 women with BAC >0 on their mammograms. The inclusion and exclusion criteria for these groups is otherwise identical. All women have had a recent mammogram and are 55-65 years old. Exclusion criteria include: ischemia, diabetes, statin/cholesterol lowering medication use, cardiovascular disease, breast cancer, breast surgery, current pregnancy/breastfeeding, and women unable to consent.
Participants will be recruited over the phone and able to e-consent if interested in the study. All participants will fill out 2 questionnaires: one on their baseline demographics/clinical history, and one on social factors. Patients will then be scheduled for bloodwork at a Northwell lab which will need to be done in a fasting state. Patients will also be schedules for a Cardiac CT scan performed at the hospital. All costs will be paid for by the study itself and patients will receive no bills from these exams.
- Conditions
- Cardiovascular Health Risk Communication, Cardiovascular (CV) Risk, Cardiovascular Disease Prevention
- Being tested
- Cardiac CT Scan, Bloodwork
- Keywords
- female health, Breast Artery Calcification, mammogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT ScanDiagnostic test
A non-contrast Cardiac CT Scan is a routine exam and a non-invasive scan to look for coronary artery calcium.
BloodworkDiagnostic test
Blood will be drawn at a Northwell Lab. Participants will need to fast before the collection. Cholesterol levels, blood sugar (hemoglobin A1C), and markers for inflammation and kidney function will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| BAC = 0 Group | Not described Receives: Diagnostic Test: Cardiac CT Scan; Diagnostic Test: Bloodwork | |
| BAC >0 Group | Not described Receives: Diagnostic Test: Cardiac CT Scan; Diagnostic Test: Bloodwork |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Artery Calcium Score
This result is obtained by the Cardiac CT Scan.
Measured: 7 days
Secondary outcomes (4)
Incidence of Dyslipidemia
Obtained through laboratory testing
Measured: 3 days
High-sensitivity C-reactive protein elevation
Obtained through laboratory testing
Measured: 3 days
Lp(a) elevation
Obtained through laboratory testing
Measured: 3 days
HbA1c
Obtained through laboratory testing
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start31 Jul 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Health Risk CommunicationStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nisha Parikh, MD, MPH, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809932
- Sponsor's protocol ID
- 25-0239
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monticciolo DL, Malak SF, Friedewald SM, Eby PR, Newell MS, Moy L, Destounis S, Leung JWT, Hendrick RE, Smetherman D. Breast Cancer Screening Recommendations Inclusive of All Women at Average Risk: Update from the ACR and Society of Breast Imaging. J Am Coll Radiol. 2021 Sep;18(9):1280-1288. doi: 10.1016/j.jacr.2021.04.021. Epub 2021 Jun 19.
PubMed 34154984Venkatesan P. New US breast cancer screening recommendations. Lancet Oncol. 2023 Jun;24(6):e242. doi: 10.1016/S1470-2045(23)00238-3. Epub 2023 May 18. No abstract available.
PubMed 37211021Koh TJW, Tan HJH, Ravi PRJ, Sng JWZ, Yeo TC, Tan BYQ, Chai P, Yeo LLL, Chan MY, Kong WKF, Wong RCC, Teo YH, Ho JSY, Teo YN, Sia CH. Association Between Breast Arterial Calcifications and Cardiovascular Disease: A Systematic Review and Meta-analysis. Can J Cardiol. 2023 Dec;39(12):1941-1950. doi: 10.1016/j.cjca.2023.07.024. Epub 2023 Jul 26.
PubMed 37506765Iribarren C, Chandra M, Lee C, Sanchez G, Sam DL, Azamian FF, Cho HM, Ding H, Wong ND, Molloi S. Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women. Circ Cardiovasc Imaging. 2022 Mar;15(3):e013526. doi: 10.1161/CIRCIMAGING.121.013526. Epub 2022 Mar 15.
PubMed 35290077Bui QM, Daniels LB. A Review of the Role of Breast Arterial Calcification for Cardiovascular Risk Stratification in Women. Circulation. 2019 Feb 19;139(8):1094-1101. doi: 10.1161/CIRCULATIONAHA.118.038092.
PubMed 30779650Bots SH, Peters SAE, Woodward M. Sex differences in coronary heart disease and stroke mortality: a global assessment of the effect of ageing between 1980 and 2010. BMJ Glob Health. 2017 Mar 27;2(2):e000298. doi: 10.1136/bmjgh-2017-000298. eCollection 2017.
PubMed 28589033Wilmot KA, O'Flaherty M, Capewell S, Ford ES, Vaccarino V. Coronary Heart Disease Mortality Declines in the United States From 1979 Through 2011: Evidence for Stagnation in Young Adults, Especially Women. Circulation. 2015 Sep 15;132(11):997-1002. doi: 10.1161/CIRCULATIONAHA.115.015293. Epub 2015 Aug 24.
PubMed 26302759
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification for Asymptomatic Women With Incidentally Found Breast Artery Calcification on Their Routine Screening Mammogram
- ClinicalTrials.gov ID
- NCT07809932
- Acronym / sponsor ID
- 25-0239
- Conditions
- Cardiovascular Health Risk Communication, Cardiovascular (CV) Risk, Cardiovascular Disease Prevention
- Keywords
- female health, Breast Artery Calcification, mammogram
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
The investigators are recruiting women with and without Breast Artery Calcification (BAC) on their mammograms. Each participant in the study will undergo bloodwork at a Northwell Health lab, a cardiac CT scan, and fill out some brief questionnaires. Results will be shared with the respective participant. At the conclusion of the study, statistical analyses will be performed to further understand the associations between BAC and cardiovascular markers.
Detailed description
Previous work has demonstrated an association between incidentally found BAC on screening mammograms and long-term major adverse cardiovascular events. However, there are no guidelines for how to manage asymptomatic women with no history of cardiovascular disease who have incidentally found BAC on a screening mammogram. This study will simulate a reasonable approach that a cardiologist might take in determining how to manage such patients. The study is unique compared with prior studies that have utilized a convenience sample, the investigators seek to gather this information in two parallel cohorts prospectively.
The investigators seek to recruit 100 women with BAC = 0 and 100 women with BAC >0 on their mammograms. The inclusion and exclusion criteria for these groups is otherwise identical. All women have had a recent mammogram and are 55-65 years old. Exclusion criteria include: ischemia, diabetes, statin/cholesterol lowering medication use, cardiovascular disease, breast cancer, breast surgery, current pregnancy/breastfeeding, and women unable to consent.
Participants will be recruited over the phone and able to e-consent if interested in the study. All participants will fill out 2 questionnaires: one on their baseline demographics/clinical history, and one on social factors. Patients will then be scheduled for bloodwork at a Northwell lab which will need to be done in a fasting state. Patients will also be schedules for a Cardiac CT scan performed at the hospital. All costs will be paid for by the study itself and patients will receive no bills from these exams.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAC = 0 Group | – | Diagnostic Test: Cardiac CT Scan, Diagnostic Test: Bloodwork |
| BAC >0 Group | – | Diagnostic Test: Cardiac CT Scan, Diagnostic Test: Bloodwork |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects will be recruited from all women who underwent a mammogram at Northwell Health.
Key inclusion criteria (2 listed)
- female
- 55-65 years old
Key exclusion criteria (8 listed)
- ischemia
- diabetes
- statin or cholesterol lowering medicine use
- cardiovascular disease: coronary artery disease, heart failure, arrhythmia, significant valvular disease
- history of breast surgery or breast cancer
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 |
|---|---|---|
| Cardiac CT ScanA non-contrast Cardiac CT Scan is a routine exam and a non-invasive scan to look for coronary artery calcium. | Diagnostic test | BAC = 0 Group, BAC >0 Group |
| BloodworkBlood will be drawn at a Northwell Lab. Participants will need to fast before the collection. Cholesterol levels, blood sugar (hemoglobin A1C), and markers for inflammation and kidney function will be analyzed. | Diagnostic test | BAC = 0 Group, BAC >0 Group |
Primary outcome
Coronary Artery Calcium Score
Time frame: 7 days
This result is obtained by the Cardiac CT Scan.
4 secondary outcomes
Incidence of Dyslipidemia
Time frame: 3 days
High-sensitivity C-reactive protein elevation
Time frame: 3 days
Lp(a) elevation
Time frame: 3 days
HbA1c
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 34154984Monticciolo DL, Malak SF, Friedewald SM, Eby PR, Newell MS, Moy L, Destounis S, Leung JWT, Hendrick RE, Smetherman D. Breast Cancer Screening Recommendations Inclusive of All Women at Average Risk: Update from the ACR and Society of Breast Imaging. J Am Coll Radiol. 2021 Sep;18(9):1280-1288. doi: 10.1016/j.jacr.2021.04.021. Epub 2021 Jun 19.
- Background: PubMed 37211021Venkatesan P. New US breast cancer screening recommendations. Lancet Oncol. 2023 Jun;24(6):e242. doi: 10.1016/S1470-2045(23)00238-3. Epub 2023 May 18. No abstract available.
- Background: PubMed 37506765Koh TJW, Tan HJH, Ravi PRJ, Sng JWZ, Yeo TC, Tan BYQ, Chai P, Yeo LLL, Chan MY, Kong WKF, Wong RCC, Teo YH, Ho JSY, Teo YN, Sia CH. Association Between Breast Arterial Calcifications and Cardiovascular Disease: A Systematic Review and Meta-analysis. Can J Cardiol. 2023 Dec;39(12):1941-1950. doi: 10.1016/j.cjca.2023.07.024. Epub 2023 Jul 26.
- Background: PubMed 35290077Iribarren C, Chandra M, Lee C, Sanchez G, Sam DL, Azamian FF, Cho HM, Ding H, Wong ND, Molloi S. Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women. Circ Cardiovasc Imaging. 2022 Mar;15(3):e013526. doi: 10.1161/CIRCIMAGING.121.013526. Epub 2022 Mar 15.
- Background: PubMed 30779650Bui QM, Daniels LB. A Review of the Role of Breast Arterial Calcification for Cardiovascular Risk Stratification in Women. Circulation. 2019 Feb 19;139(8):1094-1101. doi: 10.1161/CIRCULATIONAHA.118.038092.
- Background: PubMed 28589033Bots SH, Peters SAE, Woodward M. Sex differences in coronary heart disease and stroke mortality: a global assessment of the effect of ageing between 1980 and 2010. BMJ Glob Health. 2017 Mar 27;2(2):e000298. doi: 10.1136/bmjgh-2017-000298. eCollection 2017.
- Background: PubMed 26302759Wilmot KA, O'Flaherty M, Capewell S, Ford ES, Vaccarino V. Coronary Heart Disease Mortality Declines in the United States From 1979 Through 2011: Evidence for Stagnation in Young Adults, Especially Women. Circulation. 2015 Sep 15;132(11):997-1002. doi: 10.1161/CIRCULATIONAHA.115.015293. Epub 2015 Aug 24.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Health Risk Communication
Recruiting
The Return of Cardiovascular Information Trial (RECITE)
Health Curiosity, Cardiovascular Health Risk Communication
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.
Nisha Parikh, MD, MPH principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Health Risk Communication and Cardiovascular (CV) Risk, run by Northwell Health at 1 site in United States.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thara Ali, MD (917-951-8945, Tali7@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Artery Calcium Score (time frame: 7 days). 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 NCT07809932, which also lists 7 linked publications.
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 9 Sep 2026.