relation between calcification in blood vessels of breast with wall thickness of carotid arteries in 40-70 years age group females

Recruiting

• Conditions: vascular calcification in breast

• Registration Number: CTRI/2018/08/015189
• Lead Sponsor: kasturba medical college and hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-09
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Cases are the perimenopausal age group women with radiographically detected vascular calcifications in the breast.
• Controls are the perimenopausal age group women without breast vascular calcifications.
• Both the groups will be undergoing the Carotid doppler.

Exclusion Criteria

Patients who have vascular calcifications after 70 years of age.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to assess the relation between the breast vascular calcification with carotid intima medial thickness	time point is 0, as the carotid intima medial thickness was assessed only after subjects underwent screening mammogram

Secondary Outcome Measures

Name	Time	Method
To assess strength of association between the breast vascular calcification and carotid intima medial thickness considering other clinical risk factors for intimal calicfication	time point is 0

Trial Locations

Locations (1)

Shiridi Sai cancer block, kasturba hospital; 🇮🇳 Udupi, KARNATAKA, India

Shiridi Sai cancer block, kasturba hospital

🇮🇳Udupi, KARNATAKA, India

N PRAJEETH RAO

Principal investigator

9566751279

prajithng@gmail.com