BAC Detected by Digital Mammography Are a Potential Marker of Coronary Artery Disease

Chicago, Ill. — November 28, 2022 – Ikonopedia, a leading developer of an innovative cloud-based structured breast reporting and MQSA (Mammography Quality Standards Act) management system, announced a study, published this month in the Annals of Epidemiology using the company’s powerful analytical solutions, demonstrate age can be a significant risk factor for breast arterial calcifications (BAC). The retrospective study involved the review and analysis of more than 17,000 digital mammography patient records. The company is showcasing the analytical tools used in the study at the annual Radiological Society of North America (RSNA) conference being held November 27-30, 2022 in Chicago.
“This groundbreaking study indicates the risk of BAC doubles for every 10 years of age,” said Emily Crane, president and CEO of Ikonopedia. “BAC detected by digital mammography are a potential marker of coronary artery disease (CAD). This may portend that communication of BAC information in clinical settings could potentially prompt women to engage in preventive care for CAD.”

“This groundbreaking study indicates the risk of BAC doubles for every 10 years of age,” said Emily Crane, president and CEO of Ikonopedia.

The study found BAC prevalence was 12.3 percent overall. Age-adjusted analyses also showed higher BAC prevalence among Hispanic and Black women. It also indicated lower BAC prevalence among Ashkenazi women, nulliparous (never given birth to a child) and pre-menopausal women, those with dense breasts and breast implants, and those currently using hormone replacement therapy (HRT).

Ikonopedia’s platform includes the Insight Analytics tool, which provides comprehensive end-to-end reporting and deep mining analytic capabilities. These analytics help identify the types of cancer, breast tissue density, compliance and other high risk indicators by age group to help assist in managing patient populations.

“The study concluded that annual mammograms have the potential to serve a dual function – screening for both breast cancer and BAC,” said Crane. “This dual function could be carried out without additional radiation or prolonging the patient’s mammogram appointment. Using comprehensive analytics, such as those enabled by Ikonopedia, the assessment of BAC would add minimal time to the interpretation and reporting tasks of the breast radiologist while triggering preventative care in a more timely matter.”

The company is also highlighting its newest software upgrade including the company’s recently introduced Insight Analytics tool, which provides comprehensive end-to-end reporting and deep mining analytic capabilities within the Ikonopedia solution. These analytics help identify the types of cancer, breast tissue density, compliance and other high risk indicators by age group to help assist in managing patient populations.

About Ikonopedia

Ikonopedia was founded by three expert breast imaging Radiologists: László Tabár, MD is the author of 6 books in 10 languages on mammography and a world-renowned educator; A. Thomas Stavros, MD is the author of one of the most popular reference books in the field of breast ultrasound; and Michael J. Vendrell, MD is an expert in breast MRI and CAD design with extensive experience in breast-imaging software. For more information, visit www.ikonopedia.com.

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Media Contact:

Emily Crane
Ikonopedia
801.673.4272
emily.crane@ikonopedia.com

This article is a reprint from: Centers for Disease Control and Prevention
 

Local Reactions

Local reactions were reported by the majority of vaccine recipients and at higher rates than placebo recipients. Vaccine recipients reported higher rates of local reactions after dose 2 than dose 1. The frequency of local reactions was higher in the younger age group (aged 18 to 64 years) than the older age group (aged ≥65 years) (90.5% vs 83.9% after dose 2). Pain at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. After dose 1, the younger age group reported pain more frequently than the older age group (86.9% vs 74.0%); a similar pattern was observed after dose 2 (90.1% vs 83.4%). Axillary swelling or tenderness was the second most frequently reported local reaction. Axillary swelling or tenderness was reported more frequently in the younger age group than the older age group (16.0% vs 8.4% after dose 2). Injection site redness and swelling following either dose were reported less frequently. Redness and swelling were slightly more common after dose 2. No grade 4 local reactions were reported. Overall, the median onset of local reactions in the vaccine group was 1 day after either dose, with a median duration between 2 and 3 days. (Table 1Table 2)

Table 1. Local reactions in persons aged 18-64 years, Moderna COVID-19 vaccine and placebo

Table 1. Local reactions in persons aged 18-64 years, Moderna COVID-19 vaccine and placebo
Dose 1 Dose 2
Moderna Vaccine
N=11401
Placebo
N=11404
Moderna Vaccine
N=10357
Placebo
N=10317
Any Local, n (%)
Any 9960 (87.4) 2432 (21.3) 9371 (90.5) 2134 (20.7)
Grade 3 452 (4.0) 39 (0.3) 766 (7.4) 41 (0.4)
Paina, n (%)
Any 9908 (86.9) 2179 (19.1) 9335 (90.1) 1942 (18.8)
Grade 3 367 (3.2) 23 (0.2) 479 (4.6) 21 (0.2)
Rednessa, n (%)
Any 345 (3.0) 46 (0.4) 928 (9.0) 42 (0.4)
Severe 34 (0.3) 11 (<0.1) 206 (2.0) 12 (0.1)
Swellingb, n (%)
Any 768 (6.7) 33 (0.3) 1309 (12.6) 35 (0.3)
Grade 3 62 (0.5) 3 (<0.1) 176 (1.7) 4 (<0.1)
Axillary Swelling/Tendernessc, n (%)
Any 1322 (11.6) 567 (5.0) 1654 (16.0) 444 (4.3)
Grade 3 36 (0.3) 13 (0.1) 45 (0.4) 10 (<0.1)

a Pain grade 3: any use of prescription pain reliever or prevented daily activity; grade 4: required emergency room visit or hospitalization.

b Swelling grade 3: >100mm/>10cm; grade 4: necrosis/exfoliative dermatitis.

c Axillary swelling or tenderness was collected as a solicited local adverse reaction (i.e., lymphadenopathy: localized axillary swelling or tenderness ipsilateral to the vaccination arm); grade 3: any use of prescription pain reliever or prevented daily activity; grade 4: required emergency room visit or hospitalization.

Note: No grade 4 local reactions were reported.

Table 2. Local reactions in persons aged ≥65 years, Moderna COVID-19 vaccine and placebo

Table 2. Local reactions in persons aged ≥65 years, Moderna COVID-19 vaccine and placebo
Dose 1 Dose 2
Moderna Vaccine
N=3762
Placebo
N=3746
Moderna Vaccine
N=3587
Placebo
N=3549
Any Local, n (%)
Any 2805 (74.6) 566 (15.1) 3010 (83.9) 473 (13.3)
Grade 3 77 (2.0) 39 (1.0) 212 (5.9) 29 (0.8)
Paina, n (%)
Any 2782 (74.0) 481(12.8) 2990 (83.4) 421 (11.9)
Grade 3 50 (1.3) 32 (0.9) 96 (2.7) 17 (0.5)
Rednessa, n (%)
Any 86 (2.3) 19 (0.5) 265 (7.4) 13 (0.4)
Grade 3 8 (0.2) 2 (<0.1) 75 (2.1) 3 (<0.1)
Swellingb, n (%)
Any 166 (4.4) 19 (0.5) 386 (10.8) 13 (0.4)
Grade 3 20 (0.5) 3 (<0.1) 69 (1.9) 7 (0.2)
Axillary Swelling/Tendernessc, n (%)
Any 231 (6.1) 155 (4.1) 302 (8.4)  90 (2.5)
Grade 3 12 (0.3) 14 (0.4) 21 (0.6) 8 (0.2)

a Pain grade 3: any use of prescription pain reliever or prevented daily activity; grade 4: required emergency room visit or hospitalization.

b Swelling grade 3: >100mm/>10cm; grade 4: necrosis/exfoliative dermatitis.

c Axillary swelling or tenderness was collected as a solicited local adverse reaction (i.e. lymphadenopathy: localized axillary swelling or tenderness ipsilateral to the vaccination arm); grade 3: any use of prescription pain reliever or prevented daily activity; grade 4: required emergency room visit or hospitalization.

Note: No grade 4 local reactions were reported.

Systemic Reactions

Systemic reactions were reported by the majority of vaccine recipients and at higher rates than placebo recipients. The frequency of systemic reactions was higher in the younger age group than the older age group (81.9% vs 71.9% after dose 2). Within each age group, the frequency and severity of systemic reactions was higher after dose 2 than dose 1. For both age groups, fatigue, headache and myalgia were the most common. The majority of systemic reactions were mild or moderate in severity, after both doses and in both age groups. Fever was more common after the second dose and in the younger group (17.6%) compared to the older group (10.2%). Among vaccine recipients, the median onset of systemic reactions was 1 to 2 days after either dose, with a median duration of 2 days. Grade 4 fever (>40.0°C) was reported by four vaccine recipients after dose 1 and 11 vaccine recipients after dose 2. There was one report of grade 4 fatigue and one report of grade 4 arthralgia, both in the younger age group after dose 1. In the older age group, there was one report of grade 4 nausea or vomiting after dose 2. No other systemic grade 4 reactions were reported. (Table 3Table 4)

Table 3. Systemic reactions in persons aged 18-64 years, Moderna COVID-19 vaccine and placebo

Table 3. Systemic reactions in persons aged 18-64 years, Moderna COVID-19 vaccine and placebo
Dose 1 Dose 2
Moderna Vaccine
N=11405
Placebo
N=11406
Moderna Vaccine
N=10358
Placebo
N=10320
Any systemic, n (%)
Any 6503 (57.0) 5063 (44.4) 8484 (81.9) 3967 (38.4)
Grade 3 363 (3.2) 248 (2.2) 1801 (17.4) 215 (2.1)
Grade 4 5 (<0.1) 4 (<0.1) 10 (<0.1) 2 (<0.1)
Fevera, n (%)
Any 105 (0.9) 39 (0.3) 1806 (17.4) 38 (0.4)
Grade 3 10 (<0.1) 1 (<0.1) 168 (1.6) 1 (<0.1)
Grade 4 4 (<0.1) 4 (<0.1) 10 (<0.1) 1 (<0.1)
Headacheb, n (%)
Any 4031(35.4) 3303 (29.0) 6500 (62.8) 2617 (25.4)
Grade 3 219 (1.9) 162 (1.4) 515 (5.0) 124 (1.2)
Fatiguec, n (%)
Any 4384 (38.5) 3282 (28.8) 7002 (67.6) 2530 (24.5)
Grade 3 120 (1.1) 83 (0.7) 1099 (10.6) 81 (0.8)
Grade 4 1 (<0.1) 0 (0) 0 (0) 0 (0)
Myalgiac, n (%)
Any 2698 (23.7) 1626 (14.3) 6353 (61.3) 1312 (12.7)
Grade 3 73 (0.6) 38 (0.3) 1032 (10.0) 39 (0.4)
Arthralgiac, n (%)
Any 1892 (16.6) 1327 (11.6) 4685 (45.2) 1087 (10.5)
Grade 3 47 (0.4) 29 (0.3) 603 (5.8) 36 (0.3)
Grade 4 1 (<0.1) 0 (0) 0 (0) 0 (0)
Nausea/Vomitingd, n (%)
Any 1069 (9.3) 908 (8.0) 2209 (21.3) 754 (7.3)
Grade 3 6 (<0.1) 8 (<0.1) 8 (<0.1) 8 (<0.1)
Chillse, n (%)
Any 1051 (9.2) 730 (6.4) 5001 (48.3) 611 (5.9)
Grade 3 17 (0.1) 8 (<0.1) 151 (1.5) 14 (0.1)

a Fever – Grade 3: ≥39.0 – ≤40.0°C or ≥102.1 – ≤104.0°F; Grade 4: >40.0°C or >104.0°F
b Headache – Grade 3: significant; any use of prescription pain reliever or prevented daily activity; Grade 4: required emergency room visit or hospitalization.
c Fatigue, Myalgia, Arthralgia – Grade 3: significant; prevented daily activity; Grade 4: required emergency room visit or hospitalization.
d Nausea/Vomiting – Grade 3: prevented daily activity, required outpatient intravenous hydration; Grade 4: required emergency room visit or hospitalization for hypotensive shock.
e Chills – Grade 3: prevented daily activity and required medical intervention; Grade 4: required emergency room visit or hospitalization.

Table 4. Systemic reactions in persons aged ≥65 years, Moderna COVID-19 vaccine and placebo

Table 4. Systemic reactions in persons aged ≥65 years, Moderna COVID-19 vaccine and placebo
Dose 1 Dose 2
Moderna Vaccine
N=3761
Placebo
N=3748
Moderna Vaccine
N=3589
Placebo
N=3549
Any systemic, n (%)
Any 1818 (48.3) 1335 (35.6) 2580 (71.9) 1102 (31.1)
Grade 3 84 (2.2) 63 (1.7) 387 (10.8) 58 (1.6)
Grade 4 0 (0) 0 (0) 2 (<0.1) 1 (<0.1)
Fevera, n (%)
Any 10 (0.3) 7 (0.2) 366 (10.2) 5 (0.1)
Grade 3 1 (<0.1) 1 (<0.1) 18 (0.5) 0 (0)
Grade 4 0 (0) 2 (<0.1) 1 (<0.1) 1 (<0.1)
Headacheb, n (%)
Any 921 (33.3) 443 (11.8) 1665 (46.4) 635 (17.9)
Grade 3 30 (0.8) 34 (0.9) 107 (3.0) 32 (0.9)
Fatiguec, n (%)
Any 1251 (38.5) 851 (22.7) 2094 (58.4) 695 (19.6)
Grade 3 120 (1.1) 23 (0.6) 248 (6.9) 20 (0.6)
Myalgiac, n (%)
Any 743 (19.8) 443 (11.8) 1683 (46.9) 385 (10.8)
Grade 3 17 (0.5) 9 (0.3) 201 (5.6) 10 (0.3)
Arthralgiac, n (%)
Any 618 (16.4) 456 (12.2) 1252 (34.9) 381 (10.7)
Grade 3 13 (0.3) 8 (0.2) 122 (3.4) 7 (0.2)
Nausea/Vomitingd, n (%)
Any 194 (5.2) 166 (4.4) 425 (11.8) 129 (3.6)
Grade 3 4 (0.1) 4 (0.1) 10 (0.3) 3 (<0.1)
Grade 4 0 (0) 0 (0) 1 (<0.1) 0 (0)
Chillse, n (%)
Any 202 (5.4) 148 (4.0) 1099 (30.6) 144 (4.1)
Grade 3 7 (0.2) 6 (0.2) 27 (0.8) 2 (<0.1)

a Fever – Grade 3: ≥39.0 – ≤40.0°C or ≥102.1 – ≤104.0°F; Grade 4: >40.0°C or >104.0°F
b Headache – Grade 3: significant; any use of prescription pain reliever or prevented daily activity; Grade 4: requires emergency room visit or hospitalization.
c Fatigue, Myalgia, Arthralgia – Grade 3: significant; prevented daily activity; Grade 4: required emergency room visit or hospitalization.
d Nausea/Vomiting – Grade 3: prevented daily activity, required outpatient intravenous hydration; Grade 4: Requires emergency room visit or hospitalization for hypotensive shock.
e Chills – Grade 3: prevented daily activity and required medical intervention; Grade 4: required emergency room visit or hospitalization.

Unsolicited Adverse Events

A higher frequency of unsolicited adverse events was reported in the vaccine group compared to the placebo group and was primarily attributed to local and systemic reactogenicity following vaccination. Reports of lymphadenopathy were imbalanced with 1.1 % of persons in the vaccine group and 0.6% in the placebo group reporting such events; lymphadenopathy is plausibly related to the vaccine. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. The median duration of lymphadenopathy was 1 to 2 days. Bell’s palsy was reported by three vaccine recipients and one placebo recipient. One case of Bell’s palsy in the vaccine group was considered a serious adverse event. Currently available information is insufficient to determine a causal relationship with the vaccine.

Serious Adverse Events

Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability or incapacity. The proportions of participants who reported at least one serious adverse event were 1% in the vaccine group and 1% in the placebo group. The most common serious adverse events occurring at higher rates in the vaccine group than the placebo group were myocardial infarction (5 cases in vaccine group vs. 3 cases in placebo group), cholecystitis (3 vs. 0), and nephrolithiasis (3 vs. 0). Three serious adverse events were considered by the U.S. Food and Drug Administration (FDA) as possibly related to vaccine: the one report of intractable nausea/vomiting and two reports of facial swelling in persons who had a previous history of cosmetic filler injections. The possibility that the vaccine contributed to the serious adverse event reports of rheumatoid arthritis (n=1), peripheral edema/dyspnea with exertion (n=1), and autonomic dysfunction (n=1) cannot be excluded.

Data source: FDA briefing documentexternal icon