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Breast Disease and Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT03779217
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

Brief Summary:

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.


Condition or disease Intervention/treatment
Cardiovascular Diseases Ischemic Heart Disease Other: screening mammography Procedure: mastoplasty and breast fat excission

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Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BREast Density in Premenopausal Women is Predictive of CARdiovascular Outcomes at 10 Years of Follow-up: the BRECARD Study
Actual Study Start Date : January 2, 2008
Actual Primary Completion Date : January 2, 2021
Actual Study Completion Date : February 2, 2021

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.




Primary Outcome Measures :
  1. myocardial infarction [ Time Frame: 10 years ]
    Authors will evaluated for all follow up duration the number of myocardial infarction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779217


Locations
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Italy
Raffaele Marfella
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celestino Sardu, medical doctor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03779217    
Other Study ID Numbers: SecondUNI 17.12.2018
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases