BAC-Enhanced Information Sharing for Mammogram Screening

Recruiting at 1 trial location

Overseen By Crystalinda Rapozo

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Nitroglycerin

Disqualifiers: Coronary artery disease, Heart attack, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

37000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if women find it helpful to receive information about breast arterial calcification (BAC) in their standard mammogram results letter. BAC can be linked to heart disease, but mammogram results typically do not include this information. The study will compare two groups: one receives BAC information in their results (the BAC-Enhanced Letter), and the other does not. Women scheduled for a mammogram at Mount Sinai without known heart conditions might be suitable for this trial. The goal is to assess whether knowing about BAC influences women's healthcare decisions and lifestyle choices. As an unphased trial, this study allows participants to contribute to important research that could improve how mammogram results are communicated.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this information-sharing method is safe?

Research has shown that including information about breast arterial calcification (BAC) in mammogram results letters is safe. The BAC-Enhanced Letter adds a few lines about BAC findings to the usual results letter women receive after a mammogram. Since no additional medical treatments or procedures are involved, this trial poses no physical risks.

The goal is to determine if awareness of BAC can help women make better health choices. Studies have found a link between BAC and heart disease caused by blocked arteries, suggesting this information might be important for some women. The trial focuses on sharing information, not testing a new drug or procedure, and no negative effects have been reported from this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BAC-Enhanced Information Sharing for mammogram screening because it introduces a new way to inform patients about their Breast Arterial Calcification (BAC) results. Unlike the standard practice, which simply provides mammography results, this method includes additional BAC information in the results letter. This could empower patients with more comprehensive knowledge about their breast health, potentially leading to better-informed decisions about their care. By enhancing patient understanding of their BAC, researchers hope to improve patient outcomes and engagement with their health management.

What evidence suggests that this trial's treatments could be effective for enhancing information sharing in mammogram screening?

This trial will compare two groups: the BAC-enhanced group and the waitlist control group. Research has shown that calcium buildup in breast arteries, known as breast arterial calcification (BAC), can appear on mammograms and might be linked to heart disease risk. Studies suggest that BAC could help predict heart problems in women, especially younger ones. Participants in the BAC-enhanced group will receive a post-mammography results letter that includes information on their BAC results, potentially aiding them in making better health choices. Previous findings indicate that women want more details about their BAC status. This extra information could lead to more informed decisions about their health and lifestyle. Meanwhile, the waitlist control group will receive standard post-mammography results without BAC information, which will be provided after the study's completion. ^{1 2 6 7 8}

Who Is on the Research Team?

Guy H. Montgomery

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for women over 40 who are scheduled for a mammogram at Mount Sinai's clinics, can read and speak English or Spanish, and are willing to sign consent forms. It excludes those with cognitive/psychiatric conditions affecting study compliance, pregnant women, or those with known heart issues.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent

I am female.

Scheduled to undergo mammography at one of Mount Sinai's breast radiology clinics (e.g., Dubin Breast Center, Radiology Associates)

Exclusion Criteria

I can understand and follow the study's instructions without any mental health issues affecting me.

I have been told I have coronary artery disease.

I have had heart issues like a heart attack, stroke, or angina, or I'm on nitroglycerin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mammography and Information Sharing

Participants undergo mammography and receive a results letter, with some receiving additional BAC information

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in healthcare choices and lifestyle, including attendance at cardiovascular appointments

6 months

1 visit (virtual)

Waitlist Control Follow-up

Participants in the waitlist control group receive BAC information after study completion

6 months

What Are the Treatments Tested in This Trial?

Interventions

• BAC-Enhanced Letter
• Waitlist Control

Trial Overview The study aims to see if adding breast arterial calcification (BAC) information to post-mammography letters affects healthcare choices in women. It will measure BAC rates in a diverse group of participants and assess reactions to receiving BAC data.

How Is the Trial Designed?

Group I: Waitlist control group Experimental Treatment 2 Interventions

944 participants will receive a post-mammography results letter without BAC information, which is the current standard of care. These patients will receive BAC information following study completion (approximately 6 months after mammography).

Group II: BAC-enhanced group Experimental Treatment 1 Intervention

944 participants will receive a post-mammography results letter which includes information on their BAC results.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A survey of 598 radiologists revealed that while 87% include breast arterial calcification (BAC) in mammogram reports, only 41% report it consistently, indicating a lack of standardization in BAC reporting practices.

Most radiologists recognize BAC as a cardiovascular risk factor, but there is no consensus on whether patients should be informed about it or if BAC reporting should be standardized, with more experienced radiologists being more likely to support these practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting and Perceptions of Breast Arterial Calcification on Mammography: A Survey of ACR Radiologists. Brown, AL., Wahab, RA., Zhang, B., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) showed promising results in two patients with structural focal epilepsy, leading to seizure freedom in one patient after 4 weeks and significant reduction in seizures for the other after 20 weeks.

Both patients experienced improved quality of life with no significant adverse events reported, suggesting that taVNS could be a safe and effective treatment option for individuals with focal epilepsy and preserved cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation therapy in patients with cognitively preserved structural focal epilepsy: A case series report. Shiraishi, H., Egawa, K., Murakami, K., et al.[2023]

A study involving 227 U.S. women over 40 showed that including information about breast arterial calcification (BAC) in mammography results letters can effectively convey BAC status and encourage follow-up cardiovascular care.

Although different message framing (gain vs. loss) did not significantly impact knowledge or behavioral intentions, the study is innovative as it is the first to examine BAC results in mammography letters, suggesting a need for further research on message framing in health communications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining gain- and loss-framed messages in a novel breast cancer screening/cardiovascular context: Does framing matter? Head, KJ., Harrington, NG., Schnur, JB., et al.[2023]

Mammography, widely used for breast cancer screening, can also detect breast arterial calcifications (BAC), which are common incidental findings.

This review explores the potential of BAC as an early imaging biomarker for cardiovascular disease (CVD), suggesting that BAC could help identify individuals at risk for CVD based on mammography results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Incidental Vascular Calcifications at Mammography be Used as a Screening Biomarker for Heart and Kidney Disease? Erbil, D., Onal, EM., Demirel, C., et al.[2020]

A significant majority of mammography patients (95.8%) preferred to be informed about breast arterial calcification (BAC) findings, indicating a strong desire for awareness regarding potential cardiovascular risks.

Most patients (62.5%) preferred to receive BAC notifications from the radiology department, and a large portion (87.4%) expressed willingness to undergo coronary artery CT scans for further evaluation, highlighting the importance of effective communication in promoting cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Arterial Calcification in the Mammogram Report: The Patient Perspective. Margolies, LR., Yip, R., Hwang, E., et al.[2019]

Only 60% of Canadian radiologists are aware that breast arterial calcification (BAC) on mammograms is linked to increased cardiovascular risk, which is lower than the awareness levels among European (81%) and American (35%) radiologists.

Only 16% of Canadian radiologists report BAC in mammogram findings, significantly less than their European (62%) and American (15%) counterparts, highlighting a need for improved awareness and the establishment of national reporting guidelines for BAC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation Between Breast Arterial Calcifications and Higher Cardiovascular Risk: Awareness and Attitudes Amongst Canadian Radiologists Who Report Mammography. Heaney, RM., Zaki-Metias, KM., McKee, H., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular Vagal Nerve Stimulation (taVNS) did not show any significant effects on pain perception or nociception in healthy participants, as measured by event-related potentials and sensory testing across three experiments involving 22 and 15 subjects.

Both taVNS and standard cervical VNS (cVNS) failed to produce objective changes in behavioral and cerebral responses to pain stimuli, suggesting that the analgesic effects of taVNS may not be as effective as previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular VNS applied to experimental pain: A paired behavioral and EEG study using thermonociceptive CO2 laser. Dumoulin, M., Liberati, G., Mouraux, A., et al.[2021]

A systematic review of 261 studies revealed significant confusion in the nomenclature for transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN), with 67 full and 27 abbreviated terms identified, highlighting the need for standardization.

The most commonly used terms were 'transcutaneous vagus nerve stimulation' and 'tVNS', but there was no consistent one-to-one relationship between full and abbreviated names, indicating a lack of uniformity in terminology across different research teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. Wang, Y., Li, L., Li, S., et al.[2023]

Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive and less expensive alternative to invasive vagus nerve stimulation (VNS), which is used to treat conditions like epilepsy and depression, but requires further research to optimize stimulation sites and parameters.

tVNS has the potential to activate various brain areas and may be effective for a wide range of conditions, including medication-refractory epilepsy, depression, migraines, and more, suggesting it could become a standard treatment for enhancing autonomic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation - A brief introduction and overview. Hilz, MJ.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

In a study involving 17 healthy adults, transcutaneous auricular vagus nerve stimulation (taVNS) at the left tragus significantly increased brain activity in areas associated with the vagal pathway, indicating its potential efficacy in neuromodulation.

Compared to control stimulation at the earlobe, tragus stimulation resulted in greater activation in key brain regions, suggesting that taVNS could be a promising therapeutic approach for influencing brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Badran, BW., Dowdle, LT., Mithoefer, OJ., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04983875

Mammography and Breast Arterial Calcification: an ... The BAC-Enhanced Letter intervention includes enhancing the standard mammography results letter with a few additional lines of text informing patients of their ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.121.013526

Breast Arterial Calcification: a Novel Cardiovascular Risk ... Breast arterial calcification (BAC) is commonly seen in mammograms and is currently not considered a clinically actionable incidental finding.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9836700/

Association Between Breast Arterial Calcification on ... BAC detected as part of screening mammography is a promising noninvasive imaging marker that may enhance CAD risk prediction in women.

4. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.101283

Automated Breast Arterial Calcification Score Is Associated ... BAC is independently associated with mortality and CVD, especially among younger women. Measurement of BAC beyond presence adds incremental risk stratification.

5. withpower.com withpower.com/trial/phase-vascular-calcification-8-2021-85ba8

BAC-Enhanced Information Sharing for Mammogram ... Trial Overview The study aims to see if adding breast arterial calcification (BAC) information to post-mammography letters affects healthcare choices in women.

6. reporter.nih.gov reporter.nih.gov/search/15EEC10D4C8DC5D37598B8961CAA4A01A2FFCEB861BF/project-details/11049089

Project Details - NIH RePORTER Of those with BAC, 32%-96% have CAD. Thus, conservatively, mammography could detect over 1.5 million cases of CAD each year. Despite this potential public ...

7. diagnosticimaging.com diagnosticimaging.com/view/new-mammo-enhance-heart-program-dual-screening-breast-cancer-cardiovascular-disease

New Mammo Enhance Heart Program to ... - Diagnostic Imaging Noting that women with BAC on mammograms are over 50 percent more likely to develop heart disease or stroke, Arthy Saravanan, M.D. says the ...

8. mountsinai.org mountsinai.org/clinical-trials/mammography-breast-arterial-calcification-an-information-sharing-trial

Mammography and Breast Arterial Calcification The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results.