Cardiovascular DiseasesNCT03779217
Breast Disease and Cardiovascular Disease
An observational study of Cardiovascular Diseases and Ischemic Heart Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Ischemic Heart Disease
- What is being tested?
- screening mammography and mastoplasty and breast fat excission
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2008to 2 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Cardiovascular Diseases, Ischemic Heart Disease
- Being tested
- screening mammography, mastoplasty and breast fat excission
- Medical subject headings
- Cardiovascular Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening mammographyOther
As indicated by international guidelines authors will perform screening mammography in all asymptomatic women.
mastoplasty and breast fat excissionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: screening mammography; Procedure: mastoplasty and breast fat excission | |
| 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 Receives: Other: screening mammography; Procedure: mastoplasty and breast fat excission | |
| 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. Receives: Other: screening mammography; Procedure: mastoplasty and breast fat excission | |
| group D | In this group there are women in that the mammography shows a breast represented by almost entirely fibro-ghiandular tissue. Receives: Other: screening mammography; Procedure: mastoplasty and breast fat excission |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial infarction
Authors will evaluated for all follow up duration the number of myocardial infarction
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start2 Jan 2008
- Primary completion2 Jan 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celestino Sardu, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779217
- Sponsor's protocol ID
- SecondUNI 17.12.2018
- Status last verified
- Nov 2023
- First submitted
- 17 Dec 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sardu C, Gatta G, Pieretti G, Viola L, Sacra C, Di Grezia G, Musto L, Minelli S, La Forgia D, Capodieci M, Galiano A, Vestito A, De Lisio A, Pafundi PC, Sasso FC, Cappabianca S, Nicoletti G, Paolisso G, Marfella R. Pre-Menopausal Breast Fat Density Might Predict MACE During 10 Years of Follow-Up: The BRECARD Study. JACC Cardiovasc Imaging. 2021 Feb;14(2):426-438. doi: 10.1016/j.jcmg.2020.08.028. Epub 2020 Oct 28.
PubMed 33129736
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREast Density in Premenopausal Women is Predictive of CARdiovascular Outcomes at 10 Years of Follow-up: the BRECARD Study
- ClinicalTrials.gov ID
- NCT03779217
- Acronym / sponsor ID
- SecondUNI 17.12.2018
- Conditions
- Cardiovascular Diseases, Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 2 Jan 2008 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 19 Dec 2018 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | – | Other: screening mammography, Procedure: mastoplasty and breast fat excissionIn 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. |
| group B | – | Other: screening mammography, Procedure: mastoplasty and breast fat excissionIn 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 |
| group C | – | Other: screening mammography, Procedure: mastoplasty and breast fat excissionIn 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. |
| group D | – | Other: screening mammography, Procedure: mastoplasty and breast fat excissionIn this group there are women in that the mammography shows a breast represented by almost entirely fibro-ghiandular tissue. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| screening mammographyAs indicated by international guidelines authors will perform screening mammography in all asymptomatic women. | Other | group A, group B, group C, group D |
| mastoplasty and breast fat excissionAs 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. | Procedure or surgery | group A, group B, group C, group D |
Primary outcome
myocardial infarction
Time frame: 10 years
Authors will evaluated for all follow up duration the number of myocardial infarction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 33129736Sardu C, Gatta G, Pieretti G, Viola L, Sacra C, Di Grezia G, Musto L, Minelli S, La Forgia D, Capodieci M, Galiano A, Vestito A, De Lisio A, Pafundi PC, Sasso FC, Cappabianca S, Nicoletti G, Paolisso G, Marfella R. Pre-Menopausal Breast Fat Density Might Predict MACE During 10 Years of Follow-Up: The BRECARD Study. JACC Cardiovasc Imaging. 2021 Feb;14(2):426-438. doi: 10.1016/j.jcmg.2020.08.028. Epub 2020 Oct 28.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseases and Ischemic Heart Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Nov 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial infarction (time frame: 10 years). 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 NCT03779217, which also lists 1 linked publication.
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 24 Nov 2023.