NCT03779217

Breast Disease and Cardiovascular Disease

Completed Last updated 24 November 2023

What this trial tests

trial testing screening mammography in Cardiovascular Diseases in 10,000 participants. Completed in 2 February 2021.

Timeline

2 January 2008

Primary endpoint
2 January 2021

2 February 2021

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Status	Completed
Study type	OBSERVATIONAL
Enrollment	10,000
Start date	2 January 2008
Primary completion	2 January 2021
Estimated completion	2 February 2021
Sites	1 location across Italy

Drugs / interventions tested

• screening mammography
• mastoplasty and breast fat excission

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Ischemic Heart Disease — all drugs for Ischemic Heart Disease →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 75, female only, with Cardiovascular Diseases or Ischemic Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pre-Menopausal Breast Fat Density Might Predict MACE During 10 Years of Follow-Up: The BRECARD Study.
   Sardu C, Gatta G, Pieretti G, Viola L, et al · · 2021 · cited 49× · PMID 33129736 · DOI 10.1016/j.jcmg.2020.08.028