Breast Disease and Cardiovascular Disease

September 23, 2022 updated by: Celestino Sardu, University of Campania "Luigi Vanvitelli"

BREast Density in Premenopausal Women is Predictive of CARdiovascular Outcomes at 10 Years of Follow-up: the BRECARD Study

Cardiovascular disease (CVD) occurs less frequently in women than in juvenile men.Frequently the estrogen deficiency associated with the menopausal state affects cardiovascular outcomes. In fact, in the post-menopausal state, even younger women may experience an increase in the rate of ischemic heart disease (IHD). On the other hand, CVD may also occur in premenopausal young women, due to not well known and/or not clearly investigated mechanisms. In addition, pre-menopausal women with IHD show atypical symptoms and more frequently myocardial infarction vs. angina pectoris. In detail, in these patients IHD is frequently due to mono-vessel coronary heart disease, and to the presence of cardiovascular risk factors such as hypertension, hyperlipidemia and type 2 diabetes. So, it is clear that all these pro-atherogenic risk factors which lead to IHD in women, are significantly lower in the pre-menopausal vs. post-menopausal patients. However, the causes leading to IHD and acute coronary events in pre-menopausal women remain poorly understood and poorly investigated, and these factors might be different from the traditional coronary risk factors evident in the general population. In this context, recently some authors have shown that subcutaneous abdominal fat affects cardiovascular performance at 1 year of follow-up in patients with normoglycemia vs. pre-diabetic. Therefore, here authors can hypothesize that in a population of female subjects, the fat tissue present in the mammary gland and the different degrees of mammary adipocyte infiltration can somehow invalidate the number of cardiovascular events in women of childbearing age. In detail, the different distribution of adipose tissue in the mammary gland can influence the density of the breast, as studied by mammographic examination, which is used to divide breast density into 4 different categories:

  • Category A: the breast is represented by 80% of adipose tissue and less than 20% by fibro-glandular tissue.
  • Category B: the breast is represented by adipose tissue in the range of 50-75% and for the rest by fibro-glandular tissue.
  • Category C: the breast is represented by fatty tissuein the range 25-50% and the rest is from fibro-glandular tissue
  • Category D: the breast is represented by almost entirely fibro-glandular tissue.

Therefore, in the present study authors correlated the 4 different breast categories with CVD and 10-year follow-up IHD in women of child-bearing age. In fact, according to authors' opinion, a breast with higher fat density (category A) might influence the number of adverse cardiovascular events at 10-year follow-up in asymptomatic women. Thus, pre-menopausal women with breast tissue in category A ("fatty breast") as compared to women with prevalence of fibro-glandular tissue ("non-fatty breast") may have a higher frequency of adverse cardiac ischemic events at 10 years of follow-up.

On the other hand, the molecular pathways implied in worse CVD in these cohorts of women are not fully investigated.

Furthermore, the authors aimed to investigate the expression of inflammatory cytokines and sodium glucose transporter 2 (SGLT2) protein expression, as markers of over-inflammation, at level of breast gland in these cohorts of women. Thus, these markers were analyzed in the breast fat tissue excissed from the fatty vs. non-fatty breast women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80138
        • Raffaele Marfella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population will include asymptomatic women without neoplastic breast disease and other neoplastic diseases. These patients at enrollment did not have previous history of cardiovascular and cerebrovascular adverse events. At enrollment all women did not have a diagnosis of menopausal status.

Description

Inclusion Criteria:

  • patients with indication to receive a screening MiD, patients without breast cancer diagnosis (previous or recent diagnosis), pre-menopausal status, without inflammatory chronic disease and other neoplastic diseases. Patients without previous history of cardiovascular and cerebrovascular adverse events. Patients with indication to receive a breast reduction surgery (relief of physical pain and discomfort associated with heavy, pendulous breasts; complain of chronic back and neck pain, headaches, shoulder pain, deep bra-strap grooves, and rashes beneath both breasts; breast chronically painful as well, evidence of upper extremity neuropathy and postural changes, along with intertrigo, maceration, irritation, rashes, and other dermatologic manifestations; difficulty with many forms of exercise and the inability to find properly fitting clothe; patients that received a full package of supportive care, advising on weight loss and managing pain, physiotherapy and assessment for thoracic / shoulder girdle discomfort).

Exclusion Criteria:

  • aged < 18 years, patients without indication to receive a screening MiD, patients with breast cancer diagnosis (previous or recent diagnosis), menopausal status, inflammatory chronic disease, other neoplastic diseases; previous history of cardiovascular and cerebrovascular adverse events.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A
In this group there are women in that the mammography shows a breast represented by 80% of adipose tissue and less than 20% by fibro-glandular tissue.
Other: screening mammography
As indicated by international guidelines authors will perform screening mammography in all asymptomatic women.
Procedure: mastoplasty and breast fat excission
As indicated by guidelines, and in accordance to the breast surgery reduction criteria, the authors will practice a surgical intervention of mastoplasty. During the mastoplasty, authors will remove the breast fat tissue.
group B
In this group there are women in that the mammography shows a breast represented by adipose tissue in the range of 50-75% and for the rest by fibro-glandular tissue
Other: screening mammography
As indicated by international guidelines authors will perform screening mammography in all asymptomatic women.
Procedure: mastoplasty and breast fat excission
As indicated by guidelines, and in accordance to the breast surgery reduction criteria, the authors will practice a surgical intervention of mastoplasty. During the mastoplasty, authors will remove the breast fat tissue.
group C
In this group there are women in that the mammography shows a breast represented by adipose tissue in the range 25-50% and the rest is from fibro-glandular tissue.
Other: screening mammography
As indicated by international guidelines authors will perform screening mammography in all asymptomatic women.
Procedure: mastoplasty and breast fat excission
As indicated by guidelines, and in accordance to the breast surgery reduction criteria, the authors will practice a surgical intervention of mastoplasty. During the mastoplasty, authors will remove the breast fat tissue.
group D
In this group there are women in that the mammography shows a breast represented by almost entirely fibro-ghiandular tissue.
Other: screening mammography
As indicated by international guidelines authors will perform screening mammography in all asymptomatic women.
Procedure: mastoplasty and breast fat excission
As indicated by guidelines, and in accordance to the breast surgery reduction criteria, the authors will practice a surgical intervention of mastoplasty. During the mastoplasty, authors will remove the breast fat tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial infarction
Time Frame: 10 years
Authors will evaluated for all follow up duration the number of myocardial infarction
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2008

Primary Completion (Actual)

January 2, 2021

Study Completion (Actual)

February 2, 2021

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SecondUNI 17.12.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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