1. TITLE: Association of vascular calcification of breast with carotid intima media thickness in peri- menopausal women. 2. INTRODUCTION: Breast arterial calcification (BAC) is a common finding on mammographies, and is identified as medial calcific sclerosis of small to medium- sized muscular arteries of breast. On mammography, BAC typically appears as linear, parallel lines resembling a railroad or as ring-like calcifications in cross section. Previous reports suggest that the presence of Breast arterial calcification on routine screening mammography is associated with the presence of hypertension,diabetes mellitus,angiographically defined coronary artery disease (CAD) and increased cardiovascular mortality. Carotid intima-media thickness (C-IMT) is an easily and quickly measured noninvasive ultrasonographic marker of early atherosclerotic disease beyond the classic cardiovascular risk factors, and is directly associated with future clinical events such as myocardial infarction or stroke and cardiovascular mortality.Even though Breast arterial calcification was shown to be related with coronary artery disease and hypertension and diabetes mellitus, the association between Breast arterial calcification and Carotid intima-media thickness has not been evaluated as yet. Therefore, this study was designed to test the hypothesis that Breast arterial calcification on mammography might be associated with Carotid intima- media thickness. 3)TYPE OF STUDY: Cross sectional Study. 4) AIMS AND OBJECTIVES: AIM: To determine the relationship between vascular calcification in breast with carotid intimal thickness in the perimenopausal women OBJECTIVES: 1) To evaluate the vascular calcification in breast and correlate with carotid intimal thickness 2) To study breast vascular calcification as a predictor for cardiovascular morbidity and mortality 5)JUSTIFICATION FOR STUDY:
Mammography is a recommended screening investigation of breast for women above 40-70 years of age for early detection of the breast cancer.in this technique we use low dose x ray radiation for detection of the breast lesions. Arterial calcification is a common feature of atherosclerosis which can be elicited with conventional radiological imaging as calcium deposits in the arterial wall. The appearance of calcium in different vascular beds occurs 10-15 years later in women than in men. Breast Arterial Calcification (BAC) is an incidental finding in the mammogram which can be used to correlate the risk factors for cardiovascular morbidity and mortality by calculating the carotid intima medial thickness. 6) DEPARTMENTS INVOLVED: RADIODIAGNOSIS.
7) STUDY PERIOD: From september 2017 to September 2018
8) SAMPLE SIZE : 100 9) MATERIALS AND METHODS: This prospective study will be conducted in department of RadioDiagnosis and imaging, KMC, Manipal from September 2016 to August 2018 Institutional ethics committee approval will be obtained and informed consent will be taken from the patient prior to the procedure. A) EQUIPMENT: B) INCLUSION CRITERIA: 1) Cases are the perimenopausal age group women with radiographically detected vascular calcifications in the breast. 2) Controls are the perimenopausal age group women without breast vascular calcifications. 3) Both the groups will be undergoing the Carotid doppler. EXCLUSION CRITERIA: 1) Patients who have vascular calcifications after 70 years of age.
C) BIOLOGICAL MATERIALS REQUIRED-NIL
D) STATISTICAL ANALYSIS:Statistical analyses will be carried out on SPSS platform and the significance of the grade of vascular calcification in breast with the carotid intima medial thickness will be assessed in consideration with the other factors like the age of menopause, h/o hypertension, hyperlipidemia and diabetes mellitus and significance will be assessed using the P value.
10) DETAILED DESCRIPTION OF THE PROCEDURE: Subjects for the study are the Perimenopausal age group women who are divided into two groups cases and controls, cases are the women who are found to have vascular calcifications in breast. Control groups are perimenopausal women without breast arterial calcifications. Breast arterial calcifications (BAC) was defined as two linear calcification depositions in a conical periphery when the arterial wall is imaged longitudinally or as calcific rings when the artery is cut transversely.grading for the calcification will be done according to: Grade 1- arteries faintly outlined by calcium Grade 2- predominantly outlined by calcium Grade 3- markedly outlined by calcium. Carotid intima thickness will be measured at 1 cm proximal to the carotid bulb and 3 measurements will be taken at 1mm interval in both carotid arteries and average of these will be taken. Abnormal intimal medial thickness is considered if thickness is more than 0.9 mm. Preliminary history will be take about an ingestion of the lipid lowering agents, previous h/o diabetes, h/o any medications taken in the past. Patients with breast arterial calcification will be graded into two categories both cases and control groups will undergo carotid intima media thickness study from the both common carotid arteries and these values will be taken from the proximal, mid and distal common carotid artery with the above said statistical analysis.
11) OUTCOME MEASURES: Cases with breast arterial calcification will be graded into two categories and the average of the carotid intimal thickness will be taken based on the thickness and calcification in the carotid the relative risk of vascular calcification in breast with carotid intima medial thickness is assessed. 12) POTENTIAL RISKS AND BENEFITS: There is no direct benefit to the participant. 13) ETHICAL CONSIDERATIONS AND METHODS TO ADDRESS ISSUES: The project will be reviewed and approved before recruitment of participants. Individual informed consent will be obtained before enrollment of participant. 14) BUDGET AND PROPOSED FUNDING: NIL 15) REVIEW OF LITERATURE: In a study conducted by Sema Yildiz, Ali Yildiz, Nesrin Ertug et al concluded that the BAC on mammography is independently associated with C-IMT. Screening mammographies merit to be evaluated for the presence of BAC, which might benefit cardiovascular preventive medicine in women by predicting atherosclerosis [1]. In a study conducted by Besir erdogmus et al concluded that significant relationship exists between Brachial intimal medial thickness and breast arterial calcification but if age matching was done there will be no significant relationship between vascular calcification in breast and carotid intimal thickness [2]. In a study conducted by Ramazan Buyukkaya, Ayla Buyukkaya, Aysegul Altunkas et al concluded that BAC was found to be significantly and independently associated with C-IMT [3]. In a study conducted by Neeraj Shah, Vinod Chainani, Patrice Delafontaine et al concluded that BAC is associated with CVD, stroke, CIMT and CAC, however BAC’s relation with angiographic CAD is uncertain and presently debatable [4].
16) REFERENCES [1] Besir Erdogmus, Ramazan Buyukkaya, Ayla Buyukkaya, Burhan Yazıcı et al published an article titled “Relationship between breast arterial calcifications detected on mammography and brachial artery intima-media thickness†in Wien Klin Wochenschr (2013) 125:100–104. [2] Sema Yildiz, Ali Yildiz, Nesrin Ertug et al published an article titled “Association of breast arterial calcification and carotid intima-media thickness†in Springer Heart Vessels (2008) 23:376–382 [3] Ramazan Buyukkaya, Ayla Buyukkaya, Aysegul Altunkas et al published an article titled “Breast arterial calcifications and carotid intima-media thickness and haemodynamics: Is there any association?†in Turkish society of cardiology on 2014; 14: 378-82 [4] Neeraj Shah, Vinod Chainani, Patrice Delafontaine et al published an article titled “Mammographically Detectable Breast Arterial Calcification and Atherosclerosis†in Cardiol Rev. 2014 ; 22(2): 69–78. doi:10.1097/CRD.0b013e318295e029. |